By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute: As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. You will be the Regulatory Advisor and function as the R in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials. You will be product or project business lead for global CMRP at Takeda CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment. Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms Act as a strategic partner spanning clinical trial development through the marketing and maintenance phases of the product lifecycle. Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms. Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takedas values. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. You can understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines. Experience in prescription medicine promotion development and review process. Strong interpersonal skills with ability to demonstrate strategic and analytic thinking. Demonstrated ability to communicate clearly and concisely. Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams. Proven skills in negotiation, influencing without authority and working diplomatically through conflict. Demonstrated cross-functional people management with a desire to foster a positive team culture. Ability to work independently, take initiative and complete tasks to deadlines. Previous experience in an advertising and promotion role. Proven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards. Strong leadership, negotiation, and conflict resolution skills within cross-functional teams. Strategic mindset and ability to assess and advise regulatory impacts across the product lifecycle. Adept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance. Additional Skills: Leadership Skills can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others (both inside and outside the department) toward the accomplishment of Takeda's goals and objectives. Strategic Approach ability to identify, create and implement processes for the review of Promotional and Disease awareness materials. Change Management ability to identify, advocate and implement change positively for the organizations Demonstrates flexibility and the ability to accommodate change. Analytical and Problem-Solving Skills - Excellent ability to understand complex issues and propose achievable solutions. Communication Skills ability to express oneself clearly and concisely. Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement. Teamwork - the ability to work well in a highly cross-functional team environment. Presentation skills create and deliver presentations with appropriate messaging and focused recommendations. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsMassachusetts - VirtualCHE - Glattpark (Opfikon) - Zurich HQWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
10/24/2025
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. How you will contribute: As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. You will be the Regulatory Advisor and function as the R in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials. You will be product or project business lead for global CMRP at Takeda CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment. Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle Subject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms Act as a strategic partner spanning clinical trial development through the marketing and maintenance phases of the product lifecycle. Regulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms. Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takedas values. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. You can understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines. Experience in prescription medicine promotion development and review process. Strong interpersonal skills with ability to demonstrate strategic and analytic thinking. Demonstrated ability to communicate clearly and concisely. Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams. Proven skills in negotiation, influencing without authority and working diplomatically through conflict. Demonstrated cross-functional people management with a desire to foster a positive team culture. Ability to work independently, take initiative and complete tasks to deadlines. Previous experience in an advertising and promotion role. Proven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards. Strong leadership, negotiation, and conflict resolution skills within cross-functional teams. Strategic mindset and ability to assess and advise regulatory impacts across the product lifecycle. Adept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance. Additional Skills: Leadership Skills can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others (both inside and outside the department) toward the accomplishment of Takeda's goals and objectives. Strategic Approach ability to identify, create and implement processes for the review of Promotional and Disease awareness materials. Change Management ability to identify, advocate and implement change positively for the organizations Demonstrates flexibility and the ability to accommodate change. Analytical and Problem-Solving Skills - Excellent ability to understand complex issues and propose achievable solutions. Communication Skills ability to express oneself clearly and concisely. Interpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement. Teamwork - the ability to work well in a highly cross-functional team environment. Presentation skills create and deliver presentations with appropriate messaging and focused recommendations. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsMassachusetts - VirtualCHE - Glattpark (Opfikon) - Zurich HQWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takedas regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. ACCOUNTABILITIES: Global GRIDS Strategy Development and Realization: In partnership and collaboration with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap. Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout. Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization. Actively mentor and guide direct reports in the execution of deliverables. Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption. Data Governance and Sustainability: Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality. Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems. GRIDS Data Analytics: Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management. Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested. GRIDS System Business Ownership: Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takedas global GRIDS systems. Ensure business requirements are identified and adequately translated into system and supporting business process functionality. Support system release management, data migration and validation activities. Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization. CORE COMPETENCIES: Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach. Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively. Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change. Innovative Thinker: Proactive in embracing innovation and leveraging technology to enhance RIM processes. Results-Oriented: Focused on achieving measurable outcomes and driving continuous improvement. Analytical Skills: Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations. QUALIFICATIONS: Minimum Bachelor's Degree, MS preferred; 15+ years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems. Experience in leading global Regulatory Information, Data and Systems capabilities and teams. Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy. Ability to hold strategic conversations with Regulatory, R&D and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution. Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions. Experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. Experience with regulatory data standards, such as xEVMPD and IDMP. Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration. Understanding of global drug development & regulatory processes. Experience with Veeva RIM platform for health authority registration management. Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus. Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus. This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
10/10/2025
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takedas regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. ACCOUNTABILITIES: Global GRIDS Strategy Development and Realization: In partnership and collaboration with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap. Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout. Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization. Actively mentor and guide direct reports in the execution of deliverables. Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption. Data Governance and Sustainability: Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality. Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems. GRIDS Data Analytics: Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management. Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested. GRIDS System Business Ownership: Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takedas global GRIDS systems. Ensure business requirements are identified and adequately translated into system and supporting business process functionality. Support system release management, data migration and validation activities. Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization. CORE COMPETENCIES: Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach. Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively. Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change. Innovative Thinker: Proactive in embracing innovation and leveraging technology to enhance RIM processes. Results-Oriented: Focused on achieving measurable outcomes and driving continuous improvement. Analytical Skills: Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations. QUALIFICATIONS: Minimum Bachelor's Degree, MS preferred; 15+ years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems. Experience in leading global Regulatory Information, Data and Systems capabilities and teams. Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy. Ability to hold strategic conversations with Regulatory, R&D and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution. Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions. Experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. Experience with regulatory data standards, such as xEVMPD and IDMP. Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration. Understanding of global drug development & regulatory processes. Experience with Veeva RIM platform for health authority registration management. Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus. Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus. This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems owners, data governance, and data-related enhancements to support Takedas regulatory systems. The Head will be responsible for coordinating regulatory business systems, defining an innovative vision and roadmap, identifying areas for data and capability enhancement, and implementing such initiatives in partnership with R&D DD&T. Further, the Head will be expected to collaborate cross-functionality with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive business prioritization and then work closely with Takedas DD&T teams for execution. ACCOUNTABILITIES: Drive the future state vision of regulatory systems at Takeda Collaborate with business process teams, functional SMEs, and others to identify opportunities to enhance regulatory data management Work closely with major platform vendors to understand future state-roadmaps to define opportunities for platform and technology development Leverage inputs from business processes, reporting / analytics, user feedback and other areas to identify areas of continuous improvement Execute data and capability development roadmaps, manage timelines and budget, and collaborate with cross-functional teams to support implementation of enhancements Line management responsibility for up to 10 direct reports QUALIFICATIONS: Educational Qualifications: Minimum BS with 15+ years of experience in Life Sciences or Life Sciences consulting, with a focus on Regulatory preferred Minimum 10+ years of experience with R&D data management, system development, or related experience Regulatory Qualifications: Knowledge of regulatory/quality systems relevant to drug development Prior experience with developing and implementing data management enhancements Demonstrates strong skills with increasing independence in regulatory, program management, and technology development, such as understanding broad concepts within regulatory data and implications across the organization and globally; proactively identifies data issues; offers creative solutions and strategies, including risk mitigation strategies. Ability to assess and adapt to the industrys changing regulations, technology landscape, incorporating learnings into Takedas regulatory information management vision Prior experience in leading implementations, working with cross-functional teams, and balancing a technology-forward mindset with business stakeholder needs and requirements Interpersonal Skills: Prior experience standing up and leading teams (minimum 5 years of management experience) Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Must work well with others and within global teams Able to bring working teams together for common objectives. This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
10/10/2025
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems owners, data governance, and data-related enhancements to support Takedas regulatory systems. The Head will be responsible for coordinating regulatory business systems, defining an innovative vision and roadmap, identifying areas for data and capability enhancement, and implementing such initiatives in partnership with R&D DD&T. Further, the Head will be expected to collaborate cross-functionality with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive business prioritization and then work closely with Takedas DD&T teams for execution. ACCOUNTABILITIES: Drive the future state vision of regulatory systems at Takeda Collaborate with business process teams, functional SMEs, and others to identify opportunities to enhance regulatory data management Work closely with major platform vendors to understand future state-roadmaps to define opportunities for platform and technology development Leverage inputs from business processes, reporting / analytics, user feedback and other areas to identify areas of continuous improvement Execute data and capability development roadmaps, manage timelines and budget, and collaborate with cross-functional teams to support implementation of enhancements Line management responsibility for up to 10 direct reports QUALIFICATIONS: Educational Qualifications: Minimum BS with 15+ years of experience in Life Sciences or Life Sciences consulting, with a focus on Regulatory preferred Minimum 10+ years of experience with R&D data management, system development, or related experience Regulatory Qualifications: Knowledge of regulatory/quality systems relevant to drug development Prior experience with developing and implementing data management enhancements Demonstrates strong skills with increasing independence in regulatory, program management, and technology development, such as understanding broad concepts within regulatory data and implications across the organization and globally; proactively identifies data issues; offers creative solutions and strategies, including risk mitigation strategies. Ability to assess and adapt to the industrys changing regulations, technology landscape, incorporating learnings into Takedas regulatory information management vision Prior experience in leading implementations, working with cross-functional teams, and balancing a technology-forward mindset with business stakeholder needs and requirements Interpersonal Skills: Prior experience standing up and leading teams (minimum 5 years of management experience) Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Must work well with others and within global teams Able to bring working teams together for common objectives. This position is currently classified as hybrid by Takedas Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Required Preferred Job Industries Other
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Principal Engineer, Packaging Automation Location: Round Lake, IL At Takeda, we are driven by our purpose: better health for people, brighter future for the world. As a Principal Engineer, Packaging Automation, you'll be the site's subject matter expert for packaging automation and serialization systems, ensuring medicines reach patients safely and compliantly across the globe. This role offers the opportunity to lead high-visibility projects, troubleshoot complex automation challenges, and shape the future of serialization technology at our Round Lake site. What You'll Do Own critical serialization and vision inspection systems (Systech or similar platforms) across filling and packaging lines to keep operations reliable, compliant, and cost-effective. Lead troubleshooting and problem-solving with Maintenance and Operations to minimize downtime and drive continuous improvement. Manage system infrastructure including databases, IT network design, and user access controls. Serve as engineering lead on medium to large capital projects, representing automation in cross-functional teams. Develop automation strategies and documentation (designs, drawings, specifications, procurement packages). Lead change management & validation for serialization/vision systems, ensuring compliance with FDA and cGMP standards. Coach and mentor others - supervise contractors, support junior engineers, and deliver training for maintenance and operations teams. Continuously innovate - analyze data, identify opportunities, and implement system upgrades that enhance performance and reliability. What You Bring Bachelor's degree in Engineering (Electrical, Mechanical, Mechatronics, or related). 6+ years of experience with automation systems in an FDA-regulated environment. Hands-on experience with serialization, track & trace, or vision inspection systems (Systech preferred, other platforms welcome). Background in control systems within GMP manufacturing (pharma, biotech, or food highly relevant). Ability to troubleshoot complex systems, lead root cause analysis, and implement CAPAs. Strong knowledge of PLCs, industrial controllers, instrumentation, and network design. Experience with tools like BarTender or artwork/label management systems is a plus. Excellent communication and organizational skills to engage with cross-functional teams and leadership. Willingness to support occasional after-hours troubleshooting (rotating schedule). Why Join Us Impact that matters: your work ensures every packaged medicine is safe, compliant, and traceable-reaching patients worldwide. Cutting-edge technology: be the SME for serialization and packaging automation at a global biopharmaceutical leader. Visibility and growth: lead high-profile projects, mentor others, and expand your expertise across automation, IT, and packaging. Collaborative culture: join a cross-functional team where your ideas drive real-world improvements. Other Job Requirements Occasional cleanroom work and use of PPE. Ability to climb ladders/stairs and handle moderate physical activity. Exposure to standard chemicals with appropriate safety protections. Willingness to participate in a rotating support schedule that may include evenings, weekends, or extended hours to ensure continuity of operations. At Takeda, you'll be part of a purpose-led organization that values innovation, collaboration, and your career growth. If you're ready to take ownership of critical automation systems and make a global impact, we'd love to hear from you. About our Round Lake Facility: Takeda's manufacturing facility in Round Lake, Illinois, is an integral part of Takeda's Plasma Network. Close in proximity to both Chicago and Milwaukee, the state-of-the-art facility specializes in producing Flexbumin through the GALAXY manufacturing process. Flexbumin is albumin, contained in a flexible pouch, for patients who experience a loss of plasma volume from situations such as trauma, surgery, blood loss and burns. Round Lake supplies its product to patients all over the world, with key markets in the U.S., China, and India. Join us to make a difference. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - IL - Round Lake - Drug Delivery U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes
10/05/2025
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Principal Engineer, Packaging Automation Location: Round Lake, IL At Takeda, we are driven by our purpose: better health for people, brighter future for the world. As a Principal Engineer, Packaging Automation, you'll be the site's subject matter expert for packaging automation and serialization systems, ensuring medicines reach patients safely and compliantly across the globe. This role offers the opportunity to lead high-visibility projects, troubleshoot complex automation challenges, and shape the future of serialization technology at our Round Lake site. What You'll Do Own critical serialization and vision inspection systems (Systech or similar platforms) across filling and packaging lines to keep operations reliable, compliant, and cost-effective. Lead troubleshooting and problem-solving with Maintenance and Operations to minimize downtime and drive continuous improvement. Manage system infrastructure including databases, IT network design, and user access controls. Serve as engineering lead on medium to large capital projects, representing automation in cross-functional teams. Develop automation strategies and documentation (designs, drawings, specifications, procurement packages). Lead change management & validation for serialization/vision systems, ensuring compliance with FDA and cGMP standards. Coach and mentor others - supervise contractors, support junior engineers, and deliver training for maintenance and operations teams. Continuously innovate - analyze data, identify opportunities, and implement system upgrades that enhance performance and reliability. What You Bring Bachelor's degree in Engineering (Electrical, Mechanical, Mechatronics, or related). 6+ years of experience with automation systems in an FDA-regulated environment. Hands-on experience with serialization, track & trace, or vision inspection systems (Systech preferred, other platforms welcome). Background in control systems within GMP manufacturing (pharma, biotech, or food highly relevant). Ability to troubleshoot complex systems, lead root cause analysis, and implement CAPAs. Strong knowledge of PLCs, industrial controllers, instrumentation, and network design. Experience with tools like BarTender or artwork/label management systems is a plus. Excellent communication and organizational skills to engage with cross-functional teams and leadership. Willingness to support occasional after-hours troubleshooting (rotating schedule). Why Join Us Impact that matters: your work ensures every packaged medicine is safe, compliant, and traceable-reaching patients worldwide. Cutting-edge technology: be the SME for serialization and packaging automation at a global biopharmaceutical leader. Visibility and growth: lead high-profile projects, mentor others, and expand your expertise across automation, IT, and packaging. Collaborative culture: join a cross-functional team where your ideas drive real-world improvements. Other Job Requirements Occasional cleanroom work and use of PPE. Ability to climb ladders/stairs and handle moderate physical activity. Exposure to standard chemicals with appropriate safety protections. Willingness to participate in a rotating support schedule that may include evenings, weekends, or extended hours to ensure continuity of operations. At Takeda, you'll be part of a purpose-led organization that values innovation, collaboration, and your career growth. If you're ready to take ownership of critical automation systems and make a global impact, we'd love to hear from you. About our Round Lake Facility: Takeda's manufacturing facility in Round Lake, Illinois, is an integral part of Takeda's Plasma Network. Close in proximity to both Chicago and Milwaukee, the state-of-the-art facility specializes in producing Flexbumin through the GALAXY manufacturing process. Flexbumin is albumin, contained in a flexible pouch, for patients who experience a loss of plasma volume from situations such as trauma, surgery, blood loss and burns. Round Lake supplies its product to patients all over the world, with key markets in the U.S., China, and India. Join us to make a difference. What Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - IL - Round Lake - Drug Delivery U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - IL - Round Lake - Drug DeliveryWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role Project Manager is responsible for planning, organizing, and controlling resources and processes to achieve DD&T project objectives within scope, time, quality, and budget constraints. This role involves managing DD&T projects independently, providing guidance to lower-level professionals, and ensuring alignment with strategic business objectives. Enabling the site in their Digital & AI journey through the implementation of digital products and integrations using the GMS/GQ Northstar platform, focusing on Digital Manufacturing and Paperless Operations How you will contributeProject Planning & Coordination Manage the scope, schedule, cost, and quality of programs and projects to ensure alignment with business objectives Lead robust IT and Manufacturing Execution System (MES) projects from inception to completion, including infrastructure upgrades, software development, and systems integration. Manage resource allocation for team members based on their skills and availability to ensure efficient use of resources Provide comprehensive project oversight and transparent stakeholder communication, including regular updates on progress, risks, and key metrics Own all aspects of project delivery including schedule management, risk mitigation, stakeholder engagement, and resource planning. Risk Management Identify and assess potential risks before they impact project success, with particular focus on scope changes, resource limitations, and technical hurdles. Design and implement comprehensive risk mitigation strategies, including contingency plans that maintain project momentum while protecting key deliverables. Communication & Stakeholder Management Communicate with key stakeholders on status, risks, and accomplishments to ensure successful delivery. Guide project teams in adhering to governance policies while fostering a culture of compliance and accountability. Actively engage stakeholders throughout the project lifecycle to align expectations, incorporate feedback, and proactively address concerns Deliver clear, concise status reports to the leadership team, highlighting progress against key milestones and addressing any changes from planned objectives. What you bring to Takeda Education: Bachelor's degree in Computer Science, Statistics, Mathematics, or equivalent experience with 5+ years in IT functions. MES project experience is a plus Tools & Methodologies: Proficient in SDLC, Agile tools (e.g., Jira, MS Project, Smartsheet), and PMI Methodology. Technical Proficiency: Experienced in managing multiple technical projects, IT infrastructure, and digital product development. Project Management: Expertise in stakeholder communication, risk identification, budgeting, strategic planning, and roadmap development. Analytical Skills: Strong problem-solving, financial analysis, and value realization capabilities. Communication: Exceptional written and verbal communication skills; ability to simplify technical concepts for non-technical audiences. Program & Content Management: Skilled in organizing and optimizing project-related information and outcomes. Teamwork: Comfortable working in cross-functional teams and driving collaboration effectively. Important Considerations Physical demands: Ability to lift, push, pull, and carry up to 10 lbs. This role includes both sedentary work and walking to observe facility activities. Working environment: Controlled settings requiring special gowning (covering head, face, hands, feet, and body). No makeup, jewelry, contact lenses, or artificial nails allowed in manufacturing areas. Exposure to cold/wet environments, clean rooms, confined spaces, and temperature-sensitive storage conditions. Flexibility to work multiple shifts, weekends, and overtime as required. Occasional travel (5%). What Takeda can offer We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people. Comprehensive Healthcare: Medical, Dental, and Vision. Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan. Health and wellness programs, including onsite flu shots and health screenings. Generous time off for vacation and the option to purchase additional vacation days. Community Outreach Programs and a company match of charitable contributions. Family Planning Support. Professional training and development opportunities. Tuition reimbursement. More About Us At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide. EMPOWERING OUR PEOPLE TO SHINE Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Los Angeles U.S. Base Salary Range: $99,500.00 - $156,420.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes
10/05/2025
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role Project Manager is responsible for planning, organizing, and controlling resources and processes to achieve DD&T project objectives within scope, time, quality, and budget constraints. This role involves managing DD&T projects independently, providing guidance to lower-level professionals, and ensuring alignment with strategic business objectives. Enabling the site in their Digital & AI journey through the implementation of digital products and integrations using the GMS/GQ Northstar platform, focusing on Digital Manufacturing and Paperless Operations How you will contributeProject Planning & Coordination Manage the scope, schedule, cost, and quality of programs and projects to ensure alignment with business objectives Lead robust IT and Manufacturing Execution System (MES) projects from inception to completion, including infrastructure upgrades, software development, and systems integration. Manage resource allocation for team members based on their skills and availability to ensure efficient use of resources Provide comprehensive project oversight and transparent stakeholder communication, including regular updates on progress, risks, and key metrics Own all aspects of project delivery including schedule management, risk mitigation, stakeholder engagement, and resource planning. Risk Management Identify and assess potential risks before they impact project success, with particular focus on scope changes, resource limitations, and technical hurdles. Design and implement comprehensive risk mitigation strategies, including contingency plans that maintain project momentum while protecting key deliverables. Communication & Stakeholder Management Communicate with key stakeholders on status, risks, and accomplishments to ensure successful delivery. Guide project teams in adhering to governance policies while fostering a culture of compliance and accountability. Actively engage stakeholders throughout the project lifecycle to align expectations, incorporate feedback, and proactively address concerns Deliver clear, concise status reports to the leadership team, highlighting progress against key milestones and addressing any changes from planned objectives. What you bring to Takeda Education: Bachelor's degree in Computer Science, Statistics, Mathematics, or equivalent experience with 5+ years in IT functions. MES project experience is a plus Tools & Methodologies: Proficient in SDLC, Agile tools (e.g., Jira, MS Project, Smartsheet), and PMI Methodology. Technical Proficiency: Experienced in managing multiple technical projects, IT infrastructure, and digital product development. Project Management: Expertise in stakeholder communication, risk identification, budgeting, strategic planning, and roadmap development. Analytical Skills: Strong problem-solving, financial analysis, and value realization capabilities. Communication: Exceptional written and verbal communication skills; ability to simplify technical concepts for non-technical audiences. Program & Content Management: Skilled in organizing and optimizing project-related information and outcomes. Teamwork: Comfortable working in cross-functional teams and driving collaboration effectively. Important Considerations Physical demands: Ability to lift, push, pull, and carry up to 10 lbs. This role includes both sedentary work and walking to observe facility activities. Working environment: Controlled settings requiring special gowning (covering head, face, hands, feet, and body). No makeup, jewelry, contact lenses, or artificial nails allowed in manufacturing areas. Exposure to cold/wet environments, clean rooms, confined spaces, and temperature-sensitive storage conditions. Flexibility to work multiple shifts, weekends, and overtime as required. Occasional travel (5%). What Takeda can offer We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people. Comprehensive Healthcare: Medical, Dental, and Vision. Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan. Health and wellness programs, including onsite flu shots and health screenings. Generous time off for vacation and the option to purchase additional vacation days. Community Outreach Programs and a company match of charitable contributions. Family Planning Support. Professional training and development opportunities. Tuition reimbursement. More About Us At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide. EMPOWERING OUR PEOPLE TO SHINE Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Los Angeles U.S. Base Salary Range: $99,500.00 - $156,420.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes
Takeda Pharmaceutical
Newton Lower Falls, Massachusetts
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an IA&P Customer Excellence and Process Adherence Lead - Global Regulatory Affairs in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION ACCOUNTABILITIES: Develops appropriate tools to measure system adherence, assess risks and evaluate opportunities and makes recommendations based on findings Works closely with key stakeholders responsible for the Learning Management System to ensure system access and training adherence are aligned Works closely with key stakeholders responsible for Quality and Compliance, to ensure audit and inspection processes are aligned and accountabilities in IA&P are well defined Develop innovative on and off-boarding procedures to ensure streamlined user experience is guar-anteed. Designs, develops, and implements communication and guidance tools which create a positive customer experience and promote service excellence Proactively identify opportunities to increase service levels and mitigate any issues in service delivery within the function or across functions Supports the A&P Business Solutions team to focus on the overall priorities for the business, to maximize customer satisfaction Report back on external agencies performance and potential areas of improvement Inputs to our architectural operations vision: Align multiple systems/processes across IA&P and the broader community in collaboration with Product Owner and IA&P Leadership Support IA&P endeavors, for projects to be successfully delivered on-time, within scope and within budget Assists in the definition of project scope and objectives, involving all relevant stakeholders and ensuring monitoring and adherence feasibility DIMENSIONS AND ASPECTS: Technical/Functional (Line) Expertise Credible engagement with Quality and Compliance functions and internal LOC stakeholders to drive compliance and monitoring in the technical roadmap Be an expert / SME in EAS, DAM and Brand Portals technical development Understand the phases, processes and techniques used within a regulatory environment Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the technical roadmap Leadership Influence others at all levels & works collaboratively across different Global functions and LOCs. Strong ability to recognize and consider interdependencies of requirements and changing needs of a fast paced and dynamically complex business, translate to solutions, communicate same at a senior level Work collaboratively in a cross-functional team environment, across multiple time zones Represent IA&P and GRA in a positive and professional manner at all times Decision-making and Autonomy Take initiative and coordinate resources to drive tasks to deadlines Demonstrate technical solutioning skills, working with the Review Team and other identified parties, to drive proposals to anticipate and meet demand, influence decision making to feasible solutions Use collaboration skills and partnerships to work within the agreed Governance Model Interaction Confidently engage with external vendors and manage internal Global stakeholders, representing the needs of the business and those of IA&P and our internal partners Express self clearly and concisely at all levels, in both verbal and written communication Demonstrate maturity of thinking Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement Create and deliver clear Innovation Establish the overall vision with the relevant stakeholders, working with Vendors and developers to ensure the EAS and Brand Portals are integral to the overall solution in support of the BU's. Identifies and gains agreement for reporting, monitoring and adherence Tools and Features for the EAS and Brand Portals, including Multichannel Marketing capabilities, within the appropriate Governance Model. Works closely with relevant support teams as SME input on the existing EAS and Brand Portals and to define the support tools and enhancements to match our roadmap for the future Complexity Understand the changing needs and priorities of the business Understand complex issues and to propose timely, cost effective and achievable solutions, whilst being mindful of flexibility rather than a 'one size fits all' approach Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Bachelor Degree or above 8+ years technical experience in Electronic Approval System/s for the Healthcare/Pharmaceutical industry or 8+ years experience in successful technical project delivery & operational effectiveness (ideally in IT/Integration/Business Operations projects) with 4+ years experience working in drug, biologic, device, Regulatory Affairs or related field or equivalent from another highly regulated industry 4+ years working with or within a Quality and /or Compliance function 2+ years working with audit and inspection procedures Strong analytical skills: working knowledge of business needs assessments, business case proposals Excellent client-facing and internal written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office Desired: Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects Good working knowledge of Global copyright laws/Data Privacy Legislation/Software Licensing Restriction Ability to understand operational processes, EFPIA and International (ex-US) regulation basics on advertising and promotion for prescription products/basics in pharmaceutical promotion development Excellent English verbal and written communication skills, fluency in another European language beneficial Direct knowledge of Veeva/cloud solutions Experience of working within an AGILE Framework is a plus WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/26/2021
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an IA&P Customer Excellence and Process Adherence Lead - Global Regulatory Affairs in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION ACCOUNTABILITIES: Develops appropriate tools to measure system adherence, assess risks and evaluate opportunities and makes recommendations based on findings Works closely with key stakeholders responsible for the Learning Management System to ensure system access and training adherence are aligned Works closely with key stakeholders responsible for Quality and Compliance, to ensure audit and inspection processes are aligned and accountabilities in IA&P are well defined Develop innovative on and off-boarding procedures to ensure streamlined user experience is guar-anteed. Designs, develops, and implements communication and guidance tools which create a positive customer experience and promote service excellence Proactively identify opportunities to increase service levels and mitigate any issues in service delivery within the function or across functions Supports the A&P Business Solutions team to focus on the overall priorities for the business, to maximize customer satisfaction Report back on external agencies performance and potential areas of improvement Inputs to our architectural operations vision: Align multiple systems/processes across IA&P and the broader community in collaboration with Product Owner and IA&P Leadership Support IA&P endeavors, for projects to be successfully delivered on-time, within scope and within budget Assists in the definition of project scope and objectives, involving all relevant stakeholders and ensuring monitoring and adherence feasibility DIMENSIONS AND ASPECTS: Technical/Functional (Line) Expertise Credible engagement with Quality and Compliance functions and internal LOC stakeholders to drive compliance and monitoring in the technical roadmap Be an expert / SME in EAS, DAM and Brand Portals technical development Understand the phases, processes and techniques used within a regulatory environment Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the technical roadmap Leadership Influence others at all levels & works collaboratively across different Global functions and LOCs. Strong ability to recognize and consider interdependencies of requirements and changing needs of a fast paced and dynamically complex business, translate to solutions, communicate same at a senior level Work collaboratively in a cross-functional team environment, across multiple time zones Represent IA&P and GRA in a positive and professional manner at all times Decision-making and Autonomy Take initiative and coordinate resources to drive tasks to deadlines Demonstrate technical solutioning skills, working with the Review Team and other identified parties, to drive proposals to anticipate and meet demand, influence decision making to feasible solutions Use collaboration skills and partnerships to work within the agreed Governance Model Interaction Confidently engage with external vendors and manage internal Global stakeholders, representing the needs of the business and those of IA&P and our internal partners Express self clearly and concisely at all levels, in both verbal and written communication Demonstrate maturity of thinking Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement Create and deliver clear Innovation Establish the overall vision with the relevant stakeholders, working with Vendors and developers to ensure the EAS and Brand Portals are integral to the overall solution in support of the BU's. Identifies and gains agreement for reporting, monitoring and adherence Tools and Features for the EAS and Brand Portals, including Multichannel Marketing capabilities, within the appropriate Governance Model. Works closely with relevant support teams as SME input on the existing EAS and Brand Portals and to define the support tools and enhancements to match our roadmap for the future Complexity Understand the changing needs and priorities of the business Understand complex issues and to propose timely, cost effective and achievable solutions, whilst being mindful of flexibility rather than a 'one size fits all' approach Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Bachelor Degree or above 8+ years technical experience in Electronic Approval System/s for the Healthcare/Pharmaceutical industry or 8+ years experience in successful technical project delivery & operational effectiveness (ideally in IT/Integration/Business Operations projects) with 4+ years experience working in drug, biologic, device, Regulatory Affairs or related field or equivalent from another highly regulated industry 4+ years working with or within a Quality and /or Compliance function 2+ years working with audit and inspection procedures Strong analytical skills: working knowledge of business needs assessments, business case proposals Excellent client-facing and internal written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office Desired: Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects Good working knowledge of Global copyright laws/Data Privacy Legislation/Software Licensing Restriction Ability to understand operational processes, EFPIA and International (ex-US) regulation basics on advertising and promotion for prescription products/basics in pharmaceutical promotion development Excellent English verbal and written communication skills, fluency in another European language beneficial Direct knowledge of Veeva/cloud solutions Experience of working within an AGILE Framework is a plus WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager or a Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs working on the Research and Development team, you will be collaborate to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives. A typical will include: POSITION OBJECTIVES: Defines, develops and leads Emerging Markets strategies to maximize regulatory success to strengthen the product development plan and to enable patient access in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management as well as. Directly manage staff members, provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable. POSITION ACCOUNTABILITIES: Collaborates to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives. Manages, plans and executes the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program. Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs. Stays current with regulations / guidance's in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance. Provides regulatory expertise on Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management. Assures ongoing efforts towards fulfilment of international product approval conditions for late stage programs. Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners. Provides regulatory input to the evaluation of new business development opportunities for Emerging Markets. In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs. Supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda Emerging Markets in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required. EDUCATION, EXPERIENCE AND SKILLS: BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred. Sound experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases. 4 years of directly related regulatory experience is desirable. Sound working knowledge of regulations and guidance's governing drugs and biologics in development and life-cycle management for emerging markets; and US and/EU (relevant to role), including interaction with Health Authorities. Experience with external partners In-licensing/Out-Licensing Due-diligence Leading cross-functional teams in regulatory submissions Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Able to demonstrate skill(s) in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Generally strong in working well with others and within global teams. Experience managing relationships with CROs and/or contractors is desirable. This job posting excludes CO applicants TRAVEL REQUIREMENTS: Willingness to travel to various meetings, including overnight trips. Requires approximately up to 10-30% travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Learn more at takedajobs.com . #LI-JV1 EEO Verbiage for US Reqs Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/25/2021
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager or Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs in our Cambridge office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager or a Senior Manager, Growth & Emerging Markets - GI/NS, Global Regulatory Affairs working on the Research and Development team, you will be collaborate to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives. A typical will include: POSITION OBJECTIVES: Defines, develops and leads Emerging Markets strategies to maximize regulatory success to strengthen the product development plan and to enable patient access in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management as well as. Directly manage staff members, provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable. POSITION ACCOUNTABILITIES: Collaborates to define, develop and lead Emerging Markets strategies to maximize regulatory success towards achievement of program objectives. Manages, plans and executes the preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program. Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs. Stays current with regulations / guidance's in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance. Provides regulatory expertise on Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of registration and / or post-marketing compliance and life cycle management. Assures ongoing efforts towards fulfilment of international product approval conditions for late stage programs. Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company's consultants and Business Partners. Provides regulatory input to the evaluation of new business development opportunities for Emerging Markets. In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs. Supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda Emerging Markets in Health Authority meetings, as required. Effectively communicates and manages meeting outcome and next steps, as required. EDUCATION, EXPERIENCE AND SKILLS: BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred. Sound experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases. 4 years of directly related regulatory experience is desirable. Sound working knowledge of regulations and guidance's governing drugs and biologics in development and life-cycle management for emerging markets; and US and/EU (relevant to role), including interaction with Health Authorities. Experience with external partners In-licensing/Out-Licensing Due-diligence Leading cross-functional teams in regulatory submissions Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Able to demonstrate skill(s) in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Generally strong in working well with others and within global teams. Experience managing relationships with CROs and/or contractors is desirable. This job posting excludes CO applicants TRAVEL REQUIREMENTS: Willingness to travel to various meetings, including overnight trips. Requires approximately up to 10-30% travel. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Learn more at takedajobs.com . #LI-JV1 EEO Verbiage for US Reqs Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/25/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
09/25/2021
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Rare Genetics and Hematology. This is a remote positio Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Director working on the Global Regulatory Affairs Rare Genetics and Hematology team, you will be empowered to p rovide leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval , and a typical day will include: OBJECTIVES/PURPOSE • Provides leadership and development to global regulatory leads to ensure innovative and robust global regulatory strategies are developed to maximize regulatory success and minimize time to approval. • Develops best practices and creates a strong regulatory community across the broader Global Regulatory Affairs (GRA) organization. • Serves as an influential leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable. ACCOUNTABILITIES The Sr. Director will be responsible for managing direct reports and overseeing all global and US submission for an assigned portfolio of projects . These include ensuring that the direct reports have defined, developed and clearly communicated appropriate global strategies to maximize global regulatory success. The role may serve as an interim GRL on a global project team on a as needed basis. Partner with direct reports to ensure global market access consideration are being addressed and provide senior strategic input to interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions. Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D. Provide regulatory strategy support to diligence for licensing opportunities as appropriate Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Comprehensive understanding of the pharmaceutical industry and global regulatory strategy experience. Leadership Demonstrated ability to work across functions, regions and cultures Functional level leadership with the ability to inspire, motivate and drive results Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy Decision making responsibilities: Provide input to highly complex decisions that impact the functional area Accountable for decision making for designated function Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution Accountable for providing input to and implementing vision and strategy for designated scope-making, complexity of decisions, impact of decisions, problem-soliving) Interaction Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation Comfortable challenging the status quo and bringing forward innovative solutions Ability to take risks implementing innovative solutions, accelerating time to market Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business. Role models respect and inclusion, creating a culture that fosters innovation Complexity Ability to work in a global ecosystem (internal and external) with a high degree of complexity Deep expertise required Ability to see and understand broader, enterprise level perspective EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory experience preferred. BA accepted. 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Location and Salary Information: Location(s): Remote Base Salary Range: $240K-$270K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off ..... click apply for full job details
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/25/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/23/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/23/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/22/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/22/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Staff Engineer for our Viral Vector Lab (VVL) in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: The successful candidate will be a key, lead member within a group responsible for owning and performing non-GMP Pilot upstream cell culture operations within a viral vector lab supporting both cell and gene therapy teams. This includes vial thaw, expansion, and production of both adherent flask/stack operation as well as suspension cultures, harvest, and filtration of batches to support development and clinical timelines. They will collaborate within the upstream and downstream pilot team as well as with the process development and in-process analytics teams. This individual will lead the non-GMP upstream efforts and is responsible for independently preparing and executing routine and complex experiments and unit operations. Additionally, this position leads in planning unit operations and experiments under limited supervision and drafting support documentation (SOPs, batch records, and/or reports). They will seamlessly collaborate within the framework of cross-functional process development teams including engineers and manufacturing teams. They will possess excellent problem-solving abilities, hold strong coaching and supervisory skills, and communicate well within our multi-disciplinary environment including process development, manufacturing, in-process analytics, and manufacturing technical support teams. They will apply knowledge from various technical areas, industry practices and standards and provide quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven, and have high attention to detail. POSITION ACCOUNTABILITIES: Lead all technical operations within the Viral Vector Lab (VVL) for the upstream unit operations, both adherent and suspension, as well as process monitoring and data acquisition. Create material supply campaign plans and leads coordination efforts with Cell and Gene therapy teams to meet timeline and quantity demands. Own responsibility for aspects of tech transfer from non-GMP Pilot team of cell culture process for biologics production into cGMP manufacturing space Work with departmental and/or cross functional peers to execute on assignments, under limited supervision Document data accurately in laboratory notebooks and batch records completely as per established company guidelines/SOPs. Writes documents such as reports, protocols and internal presentations that may require substantial edits Help lead studies and technology evaluations that lead to IP, publications, external abstracts and presentations at industry events and conferences Organize and present issues and results at departmental and project meetings. Contribute significantly to project work which may include multiple projects within functional area Interpret data independently, and contributes to technical reports Identify complex technical issues, and implements solutions under limited supervision Contribute to the design of new applications/experiments/unit operations in consultation with manager. Support technology transfer through writing and consolidating technical documents. Coordinates within department as well as cross functionally with peers on projects EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 10+ years relevant industry experience Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3-5 years relevant industry experience Previous experience working in GMP manufacturing setting desired Knowledge and Skills: Analytical and Problem-Solving Skills -Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information. Stands accountable and consistently follows through on work assignments and personal objectives to deliver high quality results despite obstacles. Teamwork -- Ability to work within department groups/team. Communication Skills - Expresses ones self clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor Organization Exercises good time management skills. Effectively manages multiple priorities and outcomes of critical tasks. Technical - Proficient in use of applicable lab equipment and operations PHYSICAL DEMANDS Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes. Ability to lift, pull or push equipment requiring up to 25-75 lbs of force. Ability to stand for 6 hours in a suite. Ability to climb ladders and work platforms. Stooping or bending to check or trouble-shoot equipment operations. LINE FUNCTION SPECIFIC QUALIFICATIONS Biologics Pilot Plant non-GMP & cGMP suite: Extensive experience with cell culture is required with purification experience also desired, as this role will support both upstream and downstream operations. Experience with cell culture and aseptic techniques; Experience with laboratory equipment that supports cell culture, such as bioreactors and/or adherent culture stacks, metabolite analyzers, shake flasks, cell culture plates; Experience with using automation preferred; Experience with electronic batch record system preferred; Good understanding of chromatographic and other protein separation principles; Familiarity with use of bioseparation equipment and standard analytical assays. May be required to adjust work schedule to meet operational demands. Work includes a combination of cell culture (seed train/expansion/production bioreactor), harvest operations (filtrations or centrifugation), buffer planning and ordering, scheduling, large-scale column packing, sample forecasting and submission, metabolite or sample measurement, assisting with assembly and disassembly of process equipment, authoring batch records/SOPs or proposing document revisions, and execution of these records in both a cGMP and a non-GMP environment. The individual may contribute to the evaluation of novel, generic platform technologies that can be applied across multiple programs. TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/21/2021
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead Staff Engineer for our Viral Vector Lab (VVL) in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: The successful candidate will be a key, lead member within a group responsible for owning and performing non-GMP Pilot upstream cell culture operations within a viral vector lab supporting both cell and gene therapy teams. This includes vial thaw, expansion, and production of both adherent flask/stack operation as well as suspension cultures, harvest, and filtration of batches to support development and clinical timelines. They will collaborate within the upstream and downstream pilot team as well as with the process development and in-process analytics teams. This individual will lead the non-GMP upstream efforts and is responsible for independently preparing and executing routine and complex experiments and unit operations. Additionally, this position leads in planning unit operations and experiments under limited supervision and drafting support documentation (SOPs, batch records, and/or reports). They will seamlessly collaborate within the framework of cross-functional process development teams including engineers and manufacturing teams. They will possess excellent problem-solving abilities, hold strong coaching and supervisory skills, and communicate well within our multi-disciplinary environment including process development, manufacturing, in-process analytics, and manufacturing technical support teams. They will apply knowledge from various technical areas, industry practices and standards and provide quality and productive output that is consistently timely, reliable and reproducible. The candidate must be customer focused, results oriented, science driven, and have high attention to detail. POSITION ACCOUNTABILITIES: Lead all technical operations within the Viral Vector Lab (VVL) for the upstream unit operations, both adherent and suspension, as well as process monitoring and data acquisition. Create material supply campaign plans and leads coordination efforts with Cell and Gene therapy teams to meet timeline and quantity demands. Own responsibility for aspects of tech transfer from non-GMP Pilot team of cell culture process for biologics production into cGMP manufacturing space Work with departmental and/or cross functional peers to execute on assignments, under limited supervision Document data accurately in laboratory notebooks and batch records completely as per established company guidelines/SOPs. Writes documents such as reports, protocols and internal presentations that may require substantial edits Help lead studies and technology evaluations that lead to IP, publications, external abstracts and presentations at industry events and conferences Organize and present issues and results at departmental and project meetings. Contribute significantly to project work which may include multiple projects within functional area Interpret data independently, and contributes to technical reports Identify complex technical issues, and implements solutions under limited supervision Contribute to the design of new applications/experiments/unit operations in consultation with manager. Support technology transfer through writing and consolidating technical documents. Coordinates within department as well as cross functionally with peers on projects EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 10+ years relevant industry experience Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 7+ years relevant industry experience Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3-5 years relevant industry experience Previous experience working in GMP manufacturing setting desired Knowledge and Skills: Analytical and Problem-Solving Skills -Able to troubleshoot critical issues or problems and resolve routine issues using appropriate information. Stands accountable and consistently follows through on work assignments and personal objectives to deliver high quality results despite obstacles. Teamwork -- Ability to work within department groups/team. Communication Skills - Expresses ones self clearly and concisely within function; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor Organization Exercises good time management skills. Effectively manages multiple priorities and outcomes of critical tasks. Technical - Proficient in use of applicable lab equipment and operations PHYSICAL DEMANDS Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes. Ability to lift, pull or push equipment requiring up to 25-75 lbs of force. Ability to stand for 6 hours in a suite. Ability to climb ladders and work platforms. Stooping or bending to check or trouble-shoot equipment operations. LINE FUNCTION SPECIFIC QUALIFICATIONS Biologics Pilot Plant non-GMP & cGMP suite: Extensive experience with cell culture is required with purification experience also desired, as this role will support both upstream and downstream operations. Experience with cell culture and aseptic techniques; Experience with laboratory equipment that supports cell culture, such as bioreactors and/or adherent culture stacks, metabolite analyzers, shake flasks, cell culture plates; Experience with using automation preferred; Experience with electronic batch record system preferred; Good understanding of chromatographic and other protein separation principles; Familiarity with use of bioseparation equipment and standard analytical assays. May be required to adjust work schedule to meet operational demands. Work includes a combination of cell culture (seed train/expansion/production bioreactor), harvest operations (filtrations or centrifugation), buffer planning and ordering, scheduling, large-scale column packing, sample forecasting and submission, metabolite or sample measurement, assisting with assembly and disassembly of process equipment, authoring batch records/SOPs or proposing document revisions, and execution of these records in both a cGMP and a non-GMP environment. The individual may contribute to the evaluation of novel, generic platform technologies that can be applied across multiple programs. TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/21/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. The candidate will play an important role in maintaining human immune cell culture and production of cell products for screening and evaluation and work closely with project leader to develop assays and in vitro specific timelines. POSITION ACCOUNTABILITIES: Maintains and engineers human iPSC and primary immune cell cultures Uses a range of techniques and analytical methods such as virus preparation and transduction, flow cytometry, cytotoxicity assays, multiplex cytokine measurement to evaluate a variety of factors Works with manager or project representative to organize time and plan specific studies Owns responsibility for technical aspects of a project. Prepares experimental protocols. Conducts basic data analysis and collaborate with manager or project representative to interpret data Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports. Troubleshoot complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentation EDUCATION, EXPERIENCE AND SKILLS: Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, or MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Experience with human stem cell (e.g., induced pluripotent stem cells (iPSCs)) culture and aseptic techniques is a plus. Experience culturing T cells, NK cells is a plus. Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist II, Protein Engineer, Global Biologics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is committed to the long term strategy and vision to translate science into life- changing medicines that make critical differences for our patients around the world. The Global Biologics team within R&D consists of approx. 85 scientists across two US sites (Cambridge MA and San Diego), and aims to discover novel therapeutic large molecule biologics serving our four main therapeutic areas Oncology, Gastroenterology, Neuroscience and Rare Disease. We are excited to pursue the search for a Scientist II to join our Biotherapeutic Engineering team, a group within Takedas Global Biologics Department. The new hire will join a team of motivated and enthusiastic scientists in the Cambridge MA location. This role will be responsible for implementing workflows tailored towards protein engineering, primarily enzymes. The successful candidate will be directly involved in protein engineering from design and build of mutant libraries through to high throughput screening and characterization of candidates. The candidate should also be flexible, leading different aspects throughout the protein engineering workflow, have the ability to work independently, should have excellent communication skills working with team members to ensure smooth co-ordination of activities. POSITION ACCOUNTABILITIES: Design optimization libraries using in silico tools, followed by manipulation of the plasmid based DNA libraries. Utilize display based systems (yeast, phage) and screening to identify improved mutant proteins. Evaluate and analyze protein sequence, mutational libraries using state of the art sequence analysis software . Plan and execute appropriate in vitro experiments to optimize and characterize libraries. Co-ordinate with team members to perform high throughput plate-based production and purification of protein from yeast, mammalian cells and/or bacteria . Help to guide and implement workflows and infrastructure tailored to protein or enzyme engineering . Maintain, propagate and transform yeast, mammalian and/or bacterial cultures . Basic characterization of purified proteins using standard techniques, such as SDS- PAGE . Manage and run automation, in addition to manual steps throughout the process . Demonstrate high organization capabilities to ensure excellent tracking of ongoing and incoming targets and projects . Work closely with project team leads to develop project strategies and to coordinate work within Global biologics . Upload and track data into data management systems and maintain detailed electronic notebook . Work with a fast pace to meet program and team needs. Track record of demonstrating analytical skills, bench skills and problem-solving skills. DIMENSIONS AND ASPECTS: Technical/ functional (Line Expertise): Excellent knowledge of protein engineering and mutagenesis approaches . Demonstrated experience in protein production in mammalian or prokaryotic systems . Experience with high throughput workflows and automation . Leadership: Identifies, plans and executes novel scientific projects and may manage the work of others a direct or matrixed structure . Decision-making and Autonomy: Independently manages workload and expectations . Scientifically independent . May influence decision making within the department . Troubleshoot where necessary, and persevere to ensure that workflows are operating maximally . Interaction: Effective oral and written communication as well as strong interpersonal skills required. Innovation: Receives high level instructions on all work, determines methods on new assignments, works closely with manager, may manage junior staff . EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: PhD (2+y experience), or MS (8+ years experience) in Molecular Biology, Protein Engineering, Biochemistry or similar . Experience with protein engineering and standard mutagenesis approaches is preferred . Highly skilled in standard molecular biology techniques and cell culture techniques (yeast, bacterial, mammalian) . Experience in protein production and purification is preferred. Experience working with and troubleshooting automation and liquid handling is a plus. Effective resource and time management is essential. Effective oral and written communication as well as strong interpersonal skills required . Hard working, enthusiastic, self-motivated, team oriented with a strong collaborative spirit . WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. This job posting excludes CO applicants. #LI-SGM EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/21/2021
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientist II, Protein Engineer, Global Biologics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is committed to the long term strategy and vision to translate science into life- changing medicines that make critical differences for our patients around the world. The Global Biologics team within R&D consists of approx. 85 scientists across two US sites (Cambridge MA and San Diego), and aims to discover novel therapeutic large molecule biologics serving our four main therapeutic areas Oncology, Gastroenterology, Neuroscience and Rare Disease. We are excited to pursue the search for a Scientist II to join our Biotherapeutic Engineering team, a group within Takedas Global Biologics Department. The new hire will join a team of motivated and enthusiastic scientists in the Cambridge MA location. This role will be responsible for implementing workflows tailored towards protein engineering, primarily enzymes. The successful candidate will be directly involved in protein engineering from design and build of mutant libraries through to high throughput screening and characterization of candidates. The candidate should also be flexible, leading different aspects throughout the protein engineering workflow, have the ability to work independently, should have excellent communication skills working with team members to ensure smooth co-ordination of activities. POSITION ACCOUNTABILITIES: Design optimization libraries using in silico tools, followed by manipulation of the plasmid based DNA libraries. Utilize display based systems (yeast, phage) and screening to identify improved mutant proteins. Evaluate and analyze protein sequence, mutational libraries using state of the art sequence analysis software . Plan and execute appropriate in vitro experiments to optimize and characterize libraries. Co-ordinate with team members to perform high throughput plate-based production and purification of protein from yeast, mammalian cells and/or bacteria . Help to guide and implement workflows and infrastructure tailored to protein or enzyme engineering . Maintain, propagate and transform yeast, mammalian and/or bacterial cultures . Basic characterization of purified proteins using standard techniques, such as SDS- PAGE . Manage and run automation, in addition to manual steps throughout the process . Demonstrate high organization capabilities to ensure excellent tracking of ongoing and incoming targets and projects . Work closely with project team leads to develop project strategies and to coordinate work within Global biologics . Upload and track data into data management systems and maintain detailed electronic notebook . Work with a fast pace to meet program and team needs. Track record of demonstrating analytical skills, bench skills and problem-solving skills. DIMENSIONS AND ASPECTS: Technical/ functional (Line Expertise): Excellent knowledge of protein engineering and mutagenesis approaches . Demonstrated experience in protein production in mammalian or prokaryotic systems . Experience with high throughput workflows and automation . Leadership: Identifies, plans and executes novel scientific projects and may manage the work of others a direct or matrixed structure . Decision-making and Autonomy: Independently manages workload and expectations . Scientifically independent . May influence decision making within the department . Troubleshoot where necessary, and persevere to ensure that workflows are operating maximally . Interaction: Effective oral and written communication as well as strong interpersonal skills required. Innovation: Receives high level instructions on all work, determines methods on new assignments, works closely with manager, may manage junior staff . EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: PhD (2+y experience), or MS (8+ years experience) in Molecular Biology, Protein Engineering, Biochemistry or similar . Experience with protein engineering and standard mutagenesis approaches is preferred . Highly skilled in standard molecular biology techniques and cell culture techniques (yeast, bacterial, mammalian) . Experience in protein production and purification is preferred. Experience working with and troubleshooting automation and liquid handling is a plus. Effective resource and time management is essential. Effective oral and written communication as well as strong interpersonal skills required . Hard working, enthusiastic, self-motivated, team oriented with a strong collaborative spirit . WHAT TAKEDA CAN OFFER YOU: 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. This job posting excludes CO applicants. #LI-SGM EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Engineer II in our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Position Objective: The individual will be a member within a group responsible for performing upstream and downstream related process development activities, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Under supervision, the scope of work includes cell banking, cell expansion, bioreactor process, harvest clarification, chromatography, filtration process development activities, including optimization, characterization, scale-up, and technology transfer to CMOs and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible. Position Accountabilities: Works with departmental and/or cross functional peers to execute on assignments, under limited supervision. Prepares experimental protocols. Contributes significantly to project work which may include multiple projects within functional area. Interprets data independently, and contributes to technical reports. Identifies complex technical issues related to cell culture and protein purification process development, and implements solutions under supervision. Contributes to the design of new applications/experiments/unit operations in consultation with supervisor. Supports technology transfer through writing and consolidating technical documents. Coordinates within department as well as cross functionally with peers on projects. Maintains laboratory facilities in accordance with procedure. Present issues and discusses results in group and team settings as needed. Apply fundamental engineering and/or biological principles to practical technical challenges EDUCATION, EXPERIENCE AND SKILLS: Education and Experience: Required: Bachelors degree in engineering, microbiology, molecular biology, biochemistry, biotechnology, or related pharmaceutical science. Knowledge and Skills: Previous experience working in biologics laboratory or GMP manufacturing environment. Experience in equipment maintenance. Experience following written or standard operating procedures/work practices. Experience using certain documentation practices for data capture (batch records and/or laboratory notebooks). Excellent communication skills, both oral and written. Ability to learn new techniques, and perform multiple tasks simultaneously. Additional Desirable skills: Knowledge or prior experience with aseptic technique, solution chemistry, and laboratory equipment operation (i.e. bench-top bioreactors, AKTA Systems with UNICORN software, normal and tangential flow filtration and depth filtration). Experience in preparation of cell culture medium and solution. Experience in preparation of necessary materials (buffers, packed columns). PHYSICAL DEMANDS: Lifting of some small equipment ( TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/20/2021
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Engineer II in our Lexington, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. Position Objective: The individual will be a member within a group responsible for performing upstream and downstream related process development activities, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases. Under supervision, the scope of work includes cell banking, cell expansion, bioreactor process, harvest clarification, chromatography, filtration process development activities, including optimization, characterization, scale-up, and technology transfer to CMOs and/or internal manufacturing facilities. The individual applies basic knowledge from various technical areas, industry standards and practices, provides quality and productive output that is consistently timely, reliable and reproducible. Position Accountabilities: Works with departmental and/or cross functional peers to execute on assignments, under limited supervision. Prepares experimental protocols. Contributes significantly to project work which may include multiple projects within functional area. Interprets data independently, and contributes to technical reports. Identifies complex technical issues related to cell culture and protein purification process development, and implements solutions under supervision. Contributes to the design of new applications/experiments/unit operations in consultation with supervisor. Supports technology transfer through writing and consolidating technical documents. Coordinates within department as well as cross functionally with peers on projects. Maintains laboratory facilities in accordance with procedure. Present issues and discusses results in group and team settings as needed. Apply fundamental engineering and/or biological principles to practical technical challenges EDUCATION, EXPERIENCE AND SKILLS: Education and Experience: Required: Bachelors degree in engineering, microbiology, molecular biology, biochemistry, biotechnology, or related pharmaceutical science. Knowledge and Skills: Previous experience working in biologics laboratory or GMP manufacturing environment. Experience in equipment maintenance. Experience following written or standard operating procedures/work practices. Experience using certain documentation practices for data capture (batch records and/or laboratory notebooks). Excellent communication skills, both oral and written. Ability to learn new techniques, and perform multiple tasks simultaneously. Additional Desirable skills: Knowledge or prior experience with aseptic technique, solution chemistry, and laboratory equipment operation (i.e. bench-top bioreactors, AKTA Systems with UNICORN software, normal and tangential flow filtration and depth filtration). Experience in preparation of cell culture medium and solution. Experience in preparation of necessary materials (buffers, packed columns). PHYSICAL DEMANDS: Lifting of some small equipment ( TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Development Center Americas, Inc. is seeking a Research Scientist II in Cambridge, MA with the with the following requirements: Doctorate (PhD) degree in Chemical and Biomolecular Engineering or related field. 36 months of related experience. Will accept any level of experience in the following skills. Required Skills: Implement computational modeling to incorporate factors such as affinity, avidity, target shedding, and target turnover into drug candidate optimization; develop ad hoc computational models for designing dose level, dosing frequency, and dosing route in animal studies; Use Phoenix WinNonlin or Simbiology to integrate in vitro and in vivo data to provide quantitative characterization of the PK/PD/safety relationship; and construct mPBPKPD models of mouse and human to facilitate projection of human efficacy/safety profiles and design of clinical protocols. Apply on-line at and search for Req # R EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/20/2021
Full time
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Development Center Americas, Inc. is seeking a Research Scientist II in Cambridge, MA with the with the following requirements: Doctorate (PhD) degree in Chemical and Biomolecular Engineering or related field. 36 months of related experience. Will accept any level of experience in the following skills. Required Skills: Implement computational modeling to incorporate factors such as affinity, avidity, target shedding, and target turnover into drug candidate optimization; develop ad hoc computational models for designing dose level, dosing frequency, and dosing route in animal studies; Use Phoenix WinNonlin or Simbiology to integrate in vitro and in vivo data to provide quantitative characterization of the PK/PD/safety relationship; and construct mPBPKPD models of mouse and human to facilitate projection of human efficacy/safety profiles and design of clinical protocols. Apply on-line at and search for Req # R EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
09/20/2021
Full time
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Cell Biologist / Immunologist in our Oncology Cell Therapy Innovation group in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: We are looking for a Cell Biologist/ Immunologist/ Bio-engineer with in vitr o /ex vivo cell-based assay experience to progress oncology cell therapies programs who can independently plan and implement experiments to deliver data for cell therapy analytics. POSITION ACCOUNTABILITIES: Designs and performs in vitro/ ex vivo assays for the evaluation of T cells, NK cells or other immune cell types Uses a range of techniques and analytical methods such as multi-color flow cytometry, cytotoxicity assays and multiplex cytokine measurement to evaluate a variety of factors Maintains mammalian cell cultures, such as cancer cell lines, human iPSC, and primary immune cell cultures Works with manager or project representative to organize time and plan specific studies Conducts basic data analysis and collaborate with manager or project representative to interpret data Presents research findings clearly and effectively at team meetings Troubleshoots complex problems in creative and effective ways and actively participates in innovation and/or optimization of established processes to ensure delivery on project goals Prepares study protocols, reports and documentations Education Requirements Required: BS in a scientific discipline with 4+ years of relevant experience, OR MS in a scientific discipline with 1+ years of relevant experience Team player able to work well in a matrix team environment Self-motivated, collaborative with excellent time management and organizational skills Experience with mammalian cell culture with best practices in tissue culture is required Proficient in use of applicable lab equipment and operations Previous relevant industry experience is a plus High throughput assay experience is a plus Excellent written and verbal communication skills Knowledge and Skills: Demonstrates in-depth knowledge of currently assigned research methods Able to conduct basic data analysis Understands why a series of experiments is selected Demonstrates basic knowledge of science/technology outside specific discipline Recognizes problems and considers the significance of irregularities Receives high level instructions on all work; acts independently to determine methods on new assignments TRAVEL REQUIREMENTS May require approximately up to 0-5% travel WHAT TAKEDA CAN OFFER YOU 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-AA1 *This job posting excludes CO applicants* EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
