Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director/Principal Scientist, Virology for our site in Malvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. The candidate for this position will provide scientific leadership in the area of viral safety and be responsible for driving virology testing programs in raw materials, cell line characterization, unprocessed bulk testing and viral clearance studies to current industry standards and/or best practices. The candidate will provide technical review of external partners protocols, reports, methods, coordinate with and resolve issues with external laboratories and lead activities when required. Candidate may also manage direct reports. Responsibilities also include maintaining an awareness of current issues in viral safety for biopharmaceuticals, authoring technical documents, regulatory filings, supporting quality events and change controls, and contributing to technology transfer to collaboration partners. Responsible as a liaison with manufacturing sites quality control to provide technical oversight for clinical and commercial products. Knowledge of cell and gene therapy manufacturing and testing preferred. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives. The position requires extensive expertise in virology, including familiarity with classical cell culture, nucleic acid testing methods and advanced viral detection systems. Requires substantial communication skills including experience with regulatory agencies, technical writing ability to ensure studies are performed properly and data presented in regulatory documents are understandable to the regulatory community. The candidate will act as a mentor, advisor, and technical subject matter expert to others in the company. Qualifications A PhD in Virology, Microbiology, Biological Sciences or Biochemistry with at least 6 years of relevant business experience OR at least 3 years of experience performing progressively advanced duties at the Senior Scientist level, or equivalent training/ experience is required with a minimum of a bachelor's degree. Knowledge and hands-on experience in cell culture, virology, and nucleic acid methods are required. Knowledge of cell therapy and gene therapy manufacturing, and testing preferred. Experience working in a GMP environment is preferred. CMC regulatory experience is preferred. Experience managing people preferred. The candidate must be highly organized and capable of managing/pursuing multiple projects independently. Good written and verbal communication skills are required. Experience maintaining written records of work in the form of (electronic) notebooks, technical reports and protocols is required. Data reporting, ability to present findings to management, and experience with team-based collaborations is a must. Occasional travel and weekend work may be required. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID W
08/30/2021
Full time
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director/Principal Scientist, Virology for our site in Malvern, PA. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. The candidate for this position will provide scientific leadership in the area of viral safety and be responsible for driving virology testing programs in raw materials, cell line characterization, unprocessed bulk testing and viral clearance studies to current industry standards and/or best practices. The candidate will provide technical review of external partners protocols, reports, methods, coordinate with and resolve issues with external laboratories and lead activities when required. Candidate may also manage direct reports. Responsibilities also include maintaining an awareness of current issues in viral safety for biopharmaceuticals, authoring technical documents, regulatory filings, supporting quality events and change controls, and contributing to technology transfer to collaboration partners. Responsible as a liaison with manufacturing sites quality control to provide technical oversight for clinical and commercial products. Knowledge of cell and gene therapy manufacturing and testing preferred. The candidate is expected to work in a team environment as well as contributing individually to meet project timeline and objectives. The position requires extensive expertise in virology, including familiarity with classical cell culture, nucleic acid testing methods and advanced viral detection systems. Requires substantial communication skills including experience with regulatory agencies, technical writing ability to ensure studies are performed properly and data presented in regulatory documents are understandable to the regulatory community. The candidate will act as a mentor, advisor, and technical subject matter expert to others in the company. Qualifications A PhD in Virology, Microbiology, Biological Sciences or Biochemistry with at least 6 years of relevant business experience OR at least 3 years of experience performing progressively advanced duties at the Senior Scientist level, or equivalent training/ experience is required with a minimum of a bachelor's degree. Knowledge and hands-on experience in cell culture, virology, and nucleic acid methods are required. Knowledge of cell therapy and gene therapy manufacturing, and testing preferred. Experience working in a GMP environment is preferred. CMC regulatory experience is preferred. Experience managing people preferred. The candidate must be highly organized and capable of managing/pursuing multiple projects independently. Good written and verbal communication skills are required. Experience maintaining written records of work in the form of (electronic) notebooks, technical reports and protocols is required. Data reporting, ability to present findings to management, and experience with team-based collaborations is a must. Occasional travel and weekend work may be required. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-Pennsylvania-Malvern-200 Great Valley Parkway Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID W
Obsidian Therapeutics is pioneering the development of controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a highly motivated scientist with a strong background in cell therapy and/or process development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department, you will be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. You Will… Contribute your expertise to develop clinical/commercial manufacturing processes, cell therapy products, tech transfer to CDMOs, oversight of external manufacturing, and regulatory filings Drive the design and execution of experiments for development of the cGMP manufacturing process and associate process controls for clinical supply of cell therapy product (and related materials) meeting yield and quality targets Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods Help build the team, and train and mentor team members on experiment design, data analysis with appropriate scientific rigor and proper documentation in lab notebooks Innovate solutions to address current technical challenges and evaluate/ incorporate next-generation process technologies Supply development materials (viral vector, cell product) to support research/nonclinical studies, analytical development, and CDMO tech transfer activities Lead and support key technology transfer document preparation, technology transfer & implementation of the process, and serve as the technical point of contact for the process development function in assigned projects Establish strong relationships and collaborate closely with internal stakeholders (research, quality, regulatory, project management) Represent process development in CMC sub-teams for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents You Bring… Core Qualifications Ph.D. and 3+ years of industry experience in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology or relevant field), or MS plus 10 years relevant experience. Subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scaleup/down, cell biology/physiology Hands-on experience with product characterization methods relevant to cell therapy (e.g. flow cytometry) Highly collaborative working style, and ability to adapt in a fast-paced, rapidly developing environment Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission Bonus Qualifications Prior experience with T-cells, NK cells, induced pluripotent stem cells (iPSC), or other primary cells is a plus. Demonstrated track record with process development supporting early and/or late-stage development of biologics (cell therapy, gene therapy, vaccines, antibodies…) Experience with and technology transfer to CDMOs and external manufacturing oversight Familiar with FDA and EMA guidance documents relevant to gene and cell therapy Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities Experience with Design of Experiment (DOE) approaches and application to process development Strong working knowledge of cGMP and quality systems requirements Prior experience in managing people and matrixed teams
03/23/2021
Full time
Obsidian Therapeutics is pioneering the development of controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Our Opportunity… We're looking for a highly motivated scientist with a strong background in cell therapy and/or process development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department, you will be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients. This is a unique opportunity in a well-funded early-stage company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. Located in the heart of Cambridge, we're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. We offer competitive salary and benefits, and potential for employee ownership through stock options. You Will… Contribute your expertise to develop clinical/commercial manufacturing processes, cell therapy products, tech transfer to CDMOs, oversight of external manufacturing, and regulatory filings Drive the design and execution of experiments for development of the cGMP manufacturing process and associate process controls for clinical supply of cell therapy product (and related materials) meeting yield and quality targets Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods Help build the team, and train and mentor team members on experiment design, data analysis with appropriate scientific rigor and proper documentation in lab notebooks Innovate solutions to address current technical challenges and evaluate/ incorporate next-generation process technologies Supply development materials (viral vector, cell product) to support research/nonclinical studies, analytical development, and CDMO tech transfer activities Lead and support key technology transfer document preparation, technology transfer & implementation of the process, and serve as the technical point of contact for the process development function in assigned projects Establish strong relationships and collaborate closely with internal stakeholders (research, quality, regulatory, project management) Represent process development in CMC sub-teams for assigned projects and support project activities including authoring of relevant CMC sections in regulatory documents You Bring… Core Qualifications Ph.D. and 3+ years of industry experience in a relevant discipline (chemical engineering, biomolecular engineering, biotechnology or relevant field), or MS plus 10 years relevant experience. Subject matter expertise in mammalian cell culture and related aspects such as cell metabolism/media optimization, engineering fundamentals on cell culture scaleup/down, cell biology/physiology Hands-on experience with product characterization methods relevant to cell therapy (e.g. flow cytometry) Highly collaborative working style, and ability to adapt in a fast-paced, rapidly developing environment Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission Bonus Qualifications Prior experience with T-cells, NK cells, induced pluripotent stem cells (iPSC), or other primary cells is a plus. Demonstrated track record with process development supporting early and/or late-stage development of biologics (cell therapy, gene therapy, vaccines, antibodies…) Experience with and technology transfer to CDMOs and external manufacturing oversight Familiar with FDA and EMA guidance documents relevant to gene and cell therapy Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities Experience with Design of Experiment (DOE) approaches and application to process development Strong working knowledge of cGMP and quality systems requirements Prior experience in managing people and matrixed teams
US-CA-San Diego ID: 2 Category: Research & Development Overview Overview: AlivaMab Discovery Services ("ADS") seeks an outstanding individual with exceptional molecular biology skills for the position of Scientist/Sr. Scientist in the Molecular Biology and Protein Sciences group. The successful applicant will have responsibility for managing molecular biology activities in the Molecular Biology and Protein Science group. This position offers the opportunity for substantial career growth and the ability to help discover the medicines of tomorrow. The candidate will report to the Associate Director of Molecular Biology and Protein Science and work closely with scientists and leaders in the Antibody Discovery Group. ADS combines deep expertise and innovative technologies for the rapid discovery and development of superior antibody therapeutics. The company has developed a highly optimized fully-integrated antibody therapeutic discovery and development platform that leverages the AlivaMab Mouse technology and the ADS team's expertise to deliver diverse panels of highly characterized fully human antibody leads in unparalleled timelines. We seek talented, experienced, and enthusiastic people to join our team as we build a premier organization to meet and exceed the expectations of partners conducting antibody therapeutic discovery and development. The successful applicant will be a key contributor in a fast-growing team dedicated to delivering superior therapeutic antibody candidates that will improve outcomes for patients. Responsibilities Key Responsibilities : Initial primary responsibilities will be molecular recovery of antibody sequences, antibody sequence analysis and assessment either utilizing Sanger sequencing or NGS methods and workflows associated with each Vector construction for antibody expression and immunization campaigns, and associated workflows associated with each Independently plan and execute experiments, analyze results, and present data at team meetings Generate, organize, and maintain meticulous records all conducted experiments Qualifications Qualifications : Ph.D. with a minimum of 2 years of antibody related experience in a biotechnology or pharma company or a BS/MS with a minimum of 7 years of related experience Experience with molecular biology techniques (PCR, DNA/RNA isolation, plasmid prep, gel extraction, cloning, Sanger sequence analysis) Candidate will have NGS experience include adapter ligation, library validation, and NGS data analysis Experience working with mammalian cell culture Antibody engineering, expression, and purification is a plus Excellent trouble shooting and problem-solving capabilities Extraordinary attention to detail, planning, and organizational skills and can manage multiple projects simultaneously History of timeline-driven delivery Outstanding presentation and communication skills The successful applicant should be prepared to work in a high-energy, goal- and timeline-driven environment. Good internal and external collaborative abilities are required, including excellent listening and creative problem solving. The successful applicant will be high functioning in an environment dedicated to exceptional quality and integrity. Excellent communication skills and being able to present in front of internal and external audiences is required. Proficiency in Microsoft Office, Snap Gene, and any other programs necessary for the position are required. AlivaMab Discovery Services is a privately held technology company with an integrated therapeutic antibody discovery platform that combines innovative technologies and deep expertise to deliver superior antibody drug candidates in rapid timelines. The combined experience of the team is demonstrated by their proven track record of having executed over 200 discovery projects yielding multiple antibody drug candidates that have entered clinical trials. ADS delivers diverse panels of high affinity antibody therapeutic candidates with extensive molecular and epitope diversities, functional and kinetic characterization and superior developability profiles. The integrated platform spans from the collaborative process of designing the discovery plan to the delivery of fully human therapeutic antibodies. ADS is trusted by partners ranging from global pharmaceutical companies to virtual biotechnology organizations. AlivaMab Discovery Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
03/22/2021
Full time
US-CA-San Diego ID: 2 Category: Research & Development Overview Overview: AlivaMab Discovery Services ("ADS") seeks an outstanding individual with exceptional molecular biology skills for the position of Scientist/Sr. Scientist in the Molecular Biology and Protein Sciences group. The successful applicant will have responsibility for managing molecular biology activities in the Molecular Biology and Protein Science group. This position offers the opportunity for substantial career growth and the ability to help discover the medicines of tomorrow. The candidate will report to the Associate Director of Molecular Biology and Protein Science and work closely with scientists and leaders in the Antibody Discovery Group. ADS combines deep expertise and innovative technologies for the rapid discovery and development of superior antibody therapeutics. The company has developed a highly optimized fully-integrated antibody therapeutic discovery and development platform that leverages the AlivaMab Mouse technology and the ADS team's expertise to deliver diverse panels of highly characterized fully human antibody leads in unparalleled timelines. We seek talented, experienced, and enthusiastic people to join our team as we build a premier organization to meet and exceed the expectations of partners conducting antibody therapeutic discovery and development. The successful applicant will be a key contributor in a fast-growing team dedicated to delivering superior therapeutic antibody candidates that will improve outcomes for patients. Responsibilities Key Responsibilities : Initial primary responsibilities will be molecular recovery of antibody sequences, antibody sequence analysis and assessment either utilizing Sanger sequencing or NGS methods and workflows associated with each Vector construction for antibody expression and immunization campaigns, and associated workflows associated with each Independently plan and execute experiments, analyze results, and present data at team meetings Generate, organize, and maintain meticulous records all conducted experiments Qualifications Qualifications : Ph.D. with a minimum of 2 years of antibody related experience in a biotechnology or pharma company or a BS/MS with a minimum of 7 years of related experience Experience with molecular biology techniques (PCR, DNA/RNA isolation, plasmid prep, gel extraction, cloning, Sanger sequence analysis) Candidate will have NGS experience include adapter ligation, library validation, and NGS data analysis Experience working with mammalian cell culture Antibody engineering, expression, and purification is a plus Excellent trouble shooting and problem-solving capabilities Extraordinary attention to detail, planning, and organizational skills and can manage multiple projects simultaneously History of timeline-driven delivery Outstanding presentation and communication skills The successful applicant should be prepared to work in a high-energy, goal- and timeline-driven environment. Good internal and external collaborative abilities are required, including excellent listening and creative problem solving. The successful applicant will be high functioning in an environment dedicated to exceptional quality and integrity. Excellent communication skills and being able to present in front of internal and external audiences is required. Proficiency in Microsoft Office, Snap Gene, and any other programs necessary for the position are required. AlivaMab Discovery Services is a privately held technology company with an integrated therapeutic antibody discovery platform that combines innovative technologies and deep expertise to deliver superior antibody drug candidates in rapid timelines. The combined experience of the team is demonstrated by their proven track record of having executed over 200 discovery projects yielding multiple antibody drug candidates that have entered clinical trials. ADS delivers diverse panels of high affinity antibody therapeutic candidates with extensive molecular and epitope diversities, functional and kinetic characterization and superior developability profiles. The integrated platform spans from the collaborative process of designing the discovery plan to the delivery of fully human therapeutic antibodies. ADS is trusted by partners ranging from global pharmaceutical companies to virtual biotechnology organizations. AlivaMab Discovery Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law. PM18 #LI-DNI PI
SUMMARY: Schedule, run and maintain a process line at the West Groton Technology Research Center. This position reports to the Scientist. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Operate process line • Operates all pilot equipment located in lab, supports technology and manufacturing by running experimental trials as needed. Coordinate evaluations and/or modifications of equipment as needed to produce the desired product properties. • Work safely and ensure that all everyone working in the room observes all safety rules. • Ensure that the line equipment is properly maintained, work areas are clean and organized and that raw material stocks are replenished appropriately. • Support the development effort by producing material that meets the objectives of the trial and meets the needs of the Scientist for sample collection and information sharing. • Keep and maintain records of all trial runs including machine settings, material and time consumed and products produced. • Interface internally and externally. • Communicate plans and results effectively. • Provide technical reports and presentations to internal and external project stakeholders. • Understand the relevant end use application. • Assist Technology Scientists with the planning, media selection and process settings required to meet stated technical and processing requirements. • Keep abreast of relevant industry, applications and materials technology trends through literature, seminars and market contact. • Be knowledgeable about test methods used to determine physical characteristics of the material as well as its performance in the end use application. • Drive the development of new & novel test methods that more effectively quantify the performance of our media in the end application. • Carry out functions that must comply with ITAR standards, therefore must be a U.S. Citizen or holder or Green card (if applicable). EDUCATION AND EXPERIENCE: • High school degree or Associates degree plus three years relevant work experience OR equivalent. • Strong leadership, task management, time management and communication skills. • Effective team participant in product or process development programs. PHYSICAL REQUIREMENTS AND ENVIRONMENT: • Potential musculoskeletal stresses from repetitive motion of arms/hands, standing for prolonged periods, performing frequent bending and twisting motions, lifting of light weight objects. • Steady hands and dexterity to perform tasks repeatedly and accurately. • Perform tasks that require constant state of alertness. • Work performed in laboratory environment with potential exposure to hazardous materials. • Work performed in production area with potential exposure to large equipment/machinery and loud noises. Hollingsworth & Vose is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sexual orientation, gender identity or expression, religion, national origin, marital status, age, disability, veteran status, genetic information, or any other protected status
01/30/2021
Full time
SUMMARY: Schedule, run and maintain a process line at the West Groton Technology Research Center. This position reports to the Scientist. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: • Operate process line • Operates all pilot equipment located in lab, supports technology and manufacturing by running experimental trials as needed. Coordinate evaluations and/or modifications of equipment as needed to produce the desired product properties. • Work safely and ensure that all everyone working in the room observes all safety rules. • Ensure that the line equipment is properly maintained, work areas are clean and organized and that raw material stocks are replenished appropriately. • Support the development effort by producing material that meets the objectives of the trial and meets the needs of the Scientist for sample collection and information sharing. • Keep and maintain records of all trial runs including machine settings, material and time consumed and products produced. • Interface internally and externally. • Communicate plans and results effectively. • Provide technical reports and presentations to internal and external project stakeholders. • Understand the relevant end use application. • Assist Technology Scientists with the planning, media selection and process settings required to meet stated technical and processing requirements. • Keep abreast of relevant industry, applications and materials technology trends through literature, seminars and market contact. • Be knowledgeable about test methods used to determine physical characteristics of the material as well as its performance in the end use application. • Drive the development of new & novel test methods that more effectively quantify the performance of our media in the end application. • Carry out functions that must comply with ITAR standards, therefore must be a U.S. Citizen or holder or Green card (if applicable). EDUCATION AND EXPERIENCE: • High school degree or Associates degree plus three years relevant work experience OR equivalent. • Strong leadership, task management, time management and communication skills. • Effective team participant in product or process development programs. PHYSICAL REQUIREMENTS AND ENVIRONMENT: • Potential musculoskeletal stresses from repetitive motion of arms/hands, standing for prolonged periods, performing frequent bending and twisting motions, lifting of light weight objects. • Steady hands and dexterity to perform tasks repeatedly and accurately. • Perform tasks that require constant state of alertness. • Work performed in laboratory environment with potential exposure to hazardous materials. • Work performed in production area with potential exposure to large equipment/machinery and loud noises. Hollingsworth & Vose is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sexual orientation, gender identity or expression, religion, national origin, marital status, age, disability, veteran status, genetic information, or any other protected status
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
01/27/2021
Full time
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic, highly skilled and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director/Director within Analytical Development Quality Control department. The primary function of this Director level position in to lead the development and optimization of bioassays for the lot release, characterization, and stability and formulation assessment of conjugate vaccine intermediates, and drug substance and drug product in preclinical and clinical development. The successful candidate will also manage and build a growing group of scientists and research associates and oversee work performed in CROs. Essential Functions: • Take on end- to-end strategic responsibility for bioassay method development of intermediates, drug substance and drug products. • Lead a team of 4-5 scientists and research associate to develop, optimize, and qualify phase-appropriate a broad spectrum of immunoassay for release, stability, and formulation optimization • Drive analytical innovation and stay on top of cutting edge bioassay technology, apply innovative approaches to problem solving, and introduce and establish novel technology in house if necessary. • Collaborate with CROs to develop antibody critical reagents for the immunoassay development • Provide technical tactics and oversight of antibody purification to optimize the immunoassay performance • Develop and implement critical reagent qualification plans • Manage scientists of various levels, provide technical direction, mentorship and coaching • Cultivate a cohesive, innovative, nimble and productive team environment • Support Associate Director of QC for GMP analytical method transfer and validation at the CMOs, as well as trouble shooting of QC testing or method related issue • Collaborate with Formulation and Conjugation team to design and develop phase appropriate bioassay for in-process control and GMP quality control purpose. • Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings • Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment • Evaluate and establish contracts with CDMO/CROs for method development and GMP testing or stability studies • Manage relationships with CDMOs, including managing timelines and cost for the analytical method and GMP testing. • Provide appropriate CRO/CDMO oversight by reviewing analytical method development data, reviewing and approving analytical method development report, method validation protocols, reports, and analytical method SOPs Requirements: • PhD in Biochemistry, Analytical Chemistry or Cell Biology, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/Diagnostic industry required • Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines • Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable • A strong scientific leader who can independently design, execute, and guide effective experiments with clear goals of developing robust germane bioassay methods. and effectively and skilfully troubleshoot bioassay issue during method development, transfer, validation and QC testing in a fast pace environment • A proven track record of solving complex immunoassay and bioanalytical problems • Experiences in hybridoma technology including optimizing the immunization and fusion process, assay development, lead antibody selection and characterization. • Efficient in Interpreting data and communicating project status or risk mitigation strategies that drive critical decisions in CMC cross functional team • Demonstrated leadership and track record of successfully developing different format of bioassays by utilizing appropriate methodologies • Thorough understanding and hands on experience of MSD platform is highly desirable • Fundamental understanding of key immunology concepts related to assessment of vaccine- induced responses required • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines an d pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy • Experience in IND, NDA and BLA submission is preferred • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management • Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro and familiar with statistical software such as JMP • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Strong attention to detail supported by excellent time management and organizational skills Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/26/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic, highly skilled and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director/Director within Analytical Development Quality Control department. The primary function of this Director level position in to lead the development and optimization of bioassays for the lot release, characterization, and stability and formulation assessment of conjugate vaccine intermediates, and drug substance and drug product in preclinical and clinical development. The successful candidate will also manage and build a growing group of scientists and research associates and oversee work performed in CROs. Essential Functions: • Take on end- to-end strategic responsibility for bioassay method development of intermediates, drug substance and drug products. • Lead a team of 4-5 scientists and research associate to develop, optimize, and qualify phase-appropriate a broad spectrum of immunoassay for release, stability, and formulation optimization • Drive analytical innovation and stay on top of cutting edge bioassay technology, apply innovative approaches to problem solving, and introduce and establish novel technology in house if necessary. • Collaborate with CROs to develop antibody critical reagents for the immunoassay development • Provide technical tactics and oversight of antibody purification to optimize the immunoassay performance • Develop and implement critical reagent qualification plans • Manage scientists of various levels, provide technical direction, mentorship and coaching • Cultivate a cohesive, innovative, nimble and productive team environment • Support Associate Director of QC for GMP analytical method transfer and validation at the CMOs, as well as trouble shooting of QC testing or method related issue • Collaborate with Formulation and Conjugation team to design and develop phase appropriate bioassay for in-process control and GMP quality control purpose. • Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings • Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment • Evaluate and establish contracts with CDMO/CROs for method development and GMP testing or stability studies • Manage relationships with CDMOs, including managing timelines and cost for the analytical method and GMP testing. • Provide appropriate CRO/CDMO oversight by reviewing analytical method development data, reviewing and approving analytical method development report, method validation protocols, reports, and analytical method SOPs Requirements: • PhD in Biochemistry, Analytical Chemistry or Cell Biology, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/Diagnostic industry required • Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines • Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable • A strong scientific leader who can independently design, execute, and guide effective experiments with clear goals of developing robust germane bioassay methods. and effectively and skilfully troubleshoot bioassay issue during method development, transfer, validation and QC testing in a fast pace environment • A proven track record of solving complex immunoassay and bioanalytical problems • Experiences in hybridoma technology including optimizing the immunization and fusion process, assay development, lead antibody selection and characterization. • Efficient in Interpreting data and communicating project status or risk mitigation strategies that drive critical decisions in CMC cross functional team • Demonstrated leadership and track record of successfully developing different format of bioassays by utilizing appropriate methodologies • Thorough understanding and hands on experience of MSD platform is highly desirable • Fundamental understanding of key immunology concepts related to assessment of vaccine- induced responses required • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines an d pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy • Experience in IND, NDA and BLA submission is preferred • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management • Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro and familiar with statistical software such as JMP • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Strong attention to detail supported by excellent time management and organizational skills Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
01/23/2021
Full time
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York
Regeneron's Formulation Development Group in Tarrytown, NY is seeking an Associate Director to lead their New Technology Group. The Formulation Development Group (FDG) supports multiple modalities & technologies across various stages of development and strives to have an impact across key therapeutic like ophthalmology, infectious diseases, oncology, and immunology. As Associate Director you will lead the research, investigation & development of our novel technologies to address business needs and medical challenges. In this Associate Director role and as lead of the New Technology Group you'll lead, plan and execute activities to support development of drug delivery technologies, formulations, processes and characterization tools. A Typical Day in the Role May Look Like: Lead simultaneous development of several technologies that are applicable to different modalities (e.g. mAbs, fusion proteins, RNA therapeutics), processes (e.g. spray drying, membrane emulsification) and delivery tools (e.g. LNPs, depots, implants, pumps). Will follow strong scientific principles and practices (e.g. QbD) honing in-house tools & prototypes as well as evaluation of external technologies. Act as subject matter authority on sustained/controlled release systems. Will represent (FDG) as a SME in cross-functional settings and Senior Leadership meetings. Lead a team of 5+ scientists, providing scientific & strategic leadership for new technology projects in a cross functional setup. Independently set priorities with FDG's goals & demonstrate strategic and scientific agility (e.g. life cycle management strategies). Ensure strong strategic cohesion & communication with colleagues from Therapeutic Focus Areas, Research groups, Pre-clinical toxicology, Drug Product & Drug Substance Manufacturing, Project Management, Regulatory Sciences, Quality, Business Development, Finance and Marketing. Participate in scientific conferences and forums as Regeneron's new technology representative to gain information about novel products that are pertinent to current and future medical & business needs. Demonstrate scientific excellence through reports, publications and patents. Will be proactive in generating IP and related documentation and effectively collaborate with Regeneron's patent teams. This Role May Be For You If: You possess an in-depth understanding of formulation, process and characterization fundamentals, have strong organization and scientific skills to develop sustained release systems & novel technologies and effectively collaborate within a matrix organization to influence cross-functional teams & senior management You have strong initiative to complete results-oriented tasks and drive new technologies related to Formulation Development. You are capable of multi-tasking, working both independently and within a collaborative environment. This position requires a Ph.D. in Chemical Engineering, Pharmaceutical Chemistry, Pharmaceutical Sciences or Pharmaceutics (or related field) with 8 - 12 years of relevant shown experience. 5 + yrs demonstrated ability in leading a group of scientists. Must have provided mentorship and training to scientists and managers (Ph.D. and M.S. level) and must be a motivating and positive influence on the team. Consistent and proven track record in development of sustained/controlled release systems with experience in technology areas such as cross-linked/modified polymer science, hydrogels, biodegradable polymers, polymer fabrication processes and drug delivery systems. Experience in biologics product development including understanding of formulation, process and characterization fundamentals across modalities (e.g. mAbs, fusion proteins, RNA therapeutics) and delivery forms (e.g. LNPs, depots, implants, pumps) a plus. Experience in developing relationships with external vendors, CROs, academic institutions and scientific leaders. Strong leadership and organization skills with ability to lead cross functional teams preferred. Must be an experienced leader across settings that require frequent interaction with internal and external partners, multi-function departmental leaders as well as senior management. Must have excellent oral and written communication skills. A proven track record to quickly adapt to changes in project direction to meet the constantly evolving demands. Proven ability to think creatively and acquire solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement. Proven interpersonal and leadership skills and ability to influence others to achieve results. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
01/15/2021
Full time
Regeneron's Formulation Development Group in Tarrytown, NY is seeking an Associate Director to lead their New Technology Group. The Formulation Development Group (FDG) supports multiple modalities & technologies across various stages of development and strives to have an impact across key therapeutic like ophthalmology, infectious diseases, oncology, and immunology. As Associate Director you will lead the research, investigation & development of our novel technologies to address business needs and medical challenges. In this Associate Director role and as lead of the New Technology Group you'll lead, plan and execute activities to support development of drug delivery technologies, formulations, processes and characterization tools. A Typical Day in the Role May Look Like: Lead simultaneous development of several technologies that are applicable to different modalities (e.g. mAbs, fusion proteins, RNA therapeutics), processes (e.g. spray drying, membrane emulsification) and delivery tools (e.g. LNPs, depots, implants, pumps). Will follow strong scientific principles and practices (e.g. QbD) honing in-house tools & prototypes as well as evaluation of external technologies. Act as subject matter authority on sustained/controlled release systems. Will represent (FDG) as a SME in cross-functional settings and Senior Leadership meetings. Lead a team of 5+ scientists, providing scientific & strategic leadership for new technology projects in a cross functional setup. Independently set priorities with FDG's goals & demonstrate strategic and scientific agility (e.g. life cycle management strategies). Ensure strong strategic cohesion & communication with colleagues from Therapeutic Focus Areas, Research groups, Pre-clinical toxicology, Drug Product & Drug Substance Manufacturing, Project Management, Regulatory Sciences, Quality, Business Development, Finance and Marketing. Participate in scientific conferences and forums as Regeneron's new technology representative to gain information about novel products that are pertinent to current and future medical & business needs. Demonstrate scientific excellence through reports, publications and patents. Will be proactive in generating IP and related documentation and effectively collaborate with Regeneron's patent teams. This Role May Be For You If: You possess an in-depth understanding of formulation, process and characterization fundamentals, have strong organization and scientific skills to develop sustained release systems & novel technologies and effectively collaborate within a matrix organization to influence cross-functional teams & senior management You have strong initiative to complete results-oriented tasks and drive new technologies related to Formulation Development. You are capable of multi-tasking, working both independently and within a collaborative environment. This position requires a Ph.D. in Chemical Engineering, Pharmaceutical Chemistry, Pharmaceutical Sciences or Pharmaceutics (or related field) with 8 - 12 years of relevant shown experience. 5 + yrs demonstrated ability in leading a group of scientists. Must have provided mentorship and training to scientists and managers (Ph.D. and M.S. level) and must be a motivating and positive influence on the team. Consistent and proven track record in development of sustained/controlled release systems with experience in technology areas such as cross-linked/modified polymer science, hydrogels, biodegradable polymers, polymer fabrication processes and drug delivery systems. Experience in biologics product development including understanding of formulation, process and characterization fundamentals across modalities (e.g. mAbs, fusion proteins, RNA therapeutics) and delivery forms (e.g. LNPs, depots, implants, pumps) a plus. Experience in developing relationships with external vendors, CROs, academic institutions and scientific leaders. Strong leadership and organization skills with ability to lead cross functional teams preferred. Must be an experienced leader across settings that require frequent interaction with internal and external partners, multi-function departmental leaders as well as senior management. Must have excellent oral and written communication skills. A proven track record to quickly adapt to changes in project direction to meet the constantly evolving demands. Proven ability to think creatively and acquire solutions to complex and diverse problems. Proven record of creative, productive, and insightful analysis and achievement. Proven interpersonal and leadership skills and ability to influence others to achieve results. Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
Cognizant Technology Solutions
Teaneck, New Jersey
Cognizant is always looking for top talent. We are searching for candidates to fill future needs within the business. This job posting represents potential future employment opportunities with Cognizant. Although the position is not currently available, we want to provide you with the opportunity to express your interest in future employment opportunities with Cognizant. If a job opportunity that you may be qualified for becomes available in the future, we will notify you. At that time you can determine whether you would like to apply for the specific open position. Thank you for your interest in Cognizant career opportunities. Today, increasing globalization, rapidly-evolving technology, and a changing generation of workers and customers are challenging business assumptions. These are the forces that are transforming the way organizations compete and innovate. We call this the Future of Work - and it is no longer in the future. For progressive master's degree graduates, this is an opportunity to join a rapidly-growing and global organization with a passion for building stronger businesses for our clients. Cognizant ( , NASDAQ: CTSH) is a member of the S&P-500, Nasdaq-100, and was recently ranked as the #1 Fastest Growing "All Star" by Fortune Magazine. Cognizant leverages a highly flexible business model, a seamless global delivery network, and deep domain expertise to deliver to a long list of world-class companies that are leaders in their own space. See how joining Cognizant and embracing the Future of Work can help you drive your career forward. We are currently hiring for the following threerole opportunities. In your cover letter, please indicate your role preference: AI & Analytics Data Engineer, Visualization Engineer, or Data Scientist. AI & Analytics Data Engineer Responsibilities Integrate high-volume, high-variation, and/or high-velocity data to answers in real-time and enable clients to ask an entirely new class of questions. Deliver data pipelines to store data in a way that is accessible, performant, secure, and sustainable Prototype solutions, prepare test scripts, and conduct tests for data replication, extraction, loading, cleansing, and data modeling for data warehouses Review and validate data loaded into data lakes/warehouses for accuracy Develop proofs of concept and evaluate design options to deliver ingestion, search, metadata cataloging and scheduling of data pipelines for data modernization Data engineering in line with best practices and Cognizant's reference architecture Understand and document technical use case requirements in order to deliver data movement and transformation solutions Basic Qualifications Bachelor's degree in IT-related field and 0-3 years of IT experience Strong business communication skills (including written and oral) Experience with Java or Python development for modern data engineering Strong background in relational data models Exposure in ETL tools and Scala & Kafka Strong problem solving and analytical thinking skills Distinguishing Qualifications Full lifecycle development experience Implementation experience within the Hadoop ecosystem Industry experience (financial services, insurance, retail, healthcare, life sciences, communications) Experience leading teams Experience in developing and deploying distributed computing Big Data applications using Open Source frameworks such as Apache Spark Working knowledge of application development using Hadoop components (HDFS, HBase, Hive, Sqoop, Flume, etc.) Exposure to data analytics and data mining tools/applications such as Tableau, QlikSense /QlikView, R, or SAS Exposure to working with SQL, Relational Database Management Systems (e.g., SQL Server, Oracle) Development workflows (e.g., Microsoft VSTS) AI & Analytics Visualization Engineer Responsibilities Provide direct and interactive storytelling to clients through the use of information systems that transform data complexity into digitally-informed and intelligent data visualizations. Work with customers for addressing their visualization & narratives opportunities Frame and define strategic solution options to various stakeholders Perform analytical storytelling backed by self-developed visualizations and the articulation of IT-centric proposals to business communities Work with, and analyze, large data sets in multiple formats Embed AI within Visualization meaningfully to deliver customer outcomes R & D on new technologies and create shareable assets in the form of decks or whitepapers Basic Qualifications Master's degree in IT-related field and 0-3 years of IT experience Portfolio of exceptional visualizations including data contextualization Experience using Tableau or a comparable BI tool such as QlikView, Spotfire, D3, Looker, Jaspersoft, ThoughtSpot, Open Source Visualization tools Exposure to Data Engineering Fundamentals to deliver Visualization engagements successfully Strong problem solving and analytical thinking skills Distinguishing Qualifications Target to contribute on winning public hackathons Keep up-to-date on new analytics trends in the market, and identify where they can be implemented Focus on RPA, automation, innovations & tools, and track their benefit on RFP, project delivery Awareness of Narrative Science/ YSEOP/Automated Insights and concept of NLG/NLP etc. Big data monetization technologies including AtScale/Jethro/Arcadia data etc. Data Wrangling Technologies including Paxata/Trifacta/etc. AI & Analytics Data Scientist Responsibilities Provide context for data, business, and IT across the data management, business intelligence, and descriptive analytics domains to deliver better, faster, and smarter analytical insights to some of the world's most successful businesses - our clients. Build an in-depth understanding of the opportunity, challenge or issue domain, and its associated data Interact with large and impactful data sets across business functions Research, design, implement, and evaluate machine learning approaches and models Take the initiative in evaluating and adapting new approaches from data science research Investigate data visualization and summarization techniques for conveying key findings Communicate findings and obstacles to stakeholders to help drive the delivery to market Basic Qualifications Master's degree in IT-related or Engineering field and 0-3 years of IT experience Strong business communication skills (including written and oral) Hands-on experience in identifying and testing hypotheses, establishing correlations, selecting the right algorithms, building a predictive model using traditional, as well as machine learning algorithms, data quality assessment, imputing and transformation as well as familiarity with typical data distributions such as normal, binomials, chi-square, Poisson, etc. Hands-on experience with traditional modeling algorithms (e.g., regression, log-regression, clustering, Bayesian) Hands-on experience with the modeling platform like Python, R/R Studio Strong problem solving and analytical thinking skills Distinguishing Qualifications Ph.D. in IT-related or Engineering field and 0-3 years of IT experience Familiarity with machine learning algorithms (e.g., Extreme Gradient Boosting, SVM, Random Forest, Neural Networks, etc.) Familiarity with developing and deploying models in the Hadoop environment Experience with collaborative development workflows (e.g., Microsoft VSTS) Exposure to working with SQL, Relational Database Management Systems (e.g., SQL Server, Oracle) Learning & Development Your on-the-job success and Cognizant career advancement is important to us. To help you construct a platform for personal and professional growth, your Cognizant journey will include a learning program catering to your skill level and role. Gain niche Data Sciences skills vital to success in your new role Create job maneuverability in emerging and established technologies Our commitment to you Your innovative thinking and successes will be rewarded with opportunities for career advancement You can make a difference working with high-profile clients and projects You will be supported by a high-caliber analytics ecosystem New skills, knowledge, and training through our global network of experts Competitive salary including paid time off, a 401K matching program, an extensive healthcare benefits suite, and more Applicants must be willing to relocate - our business model requires our consultants to be as close to the client site as possible. Cognizant will provide relocation assistance. Cognizant will not sponsor H-1B or other U.S. work authorization, or lawful permanent residence (otherwise known as a "====") for this role. Cognizant is an equal opportunity employer provider and committed to creating a diverse environment. Cognizant considers all applicants without regard to race, creed, color..... click apply for full job details
10/02/2020
Full time
Cognizant is always looking for top talent. We are searching for candidates to fill future needs within the business. This job posting represents potential future employment opportunities with Cognizant. Although the position is not currently available, we want to provide you with the opportunity to express your interest in future employment opportunities with Cognizant. If a job opportunity that you may be qualified for becomes available in the future, we will notify you. At that time you can determine whether you would like to apply for the specific open position. Thank you for your interest in Cognizant career opportunities. Today, increasing globalization, rapidly-evolving technology, and a changing generation of workers and customers are challenging business assumptions. These are the forces that are transforming the way organizations compete and innovate. We call this the Future of Work - and it is no longer in the future. For progressive master's degree graduates, this is an opportunity to join a rapidly-growing and global organization with a passion for building stronger businesses for our clients. Cognizant ( , NASDAQ: CTSH) is a member of the S&P-500, Nasdaq-100, and was recently ranked as the #1 Fastest Growing "All Star" by Fortune Magazine. Cognizant leverages a highly flexible business model, a seamless global delivery network, and deep domain expertise to deliver to a long list of world-class companies that are leaders in their own space. See how joining Cognizant and embracing the Future of Work can help you drive your career forward. We are currently hiring for the following threerole opportunities. In your cover letter, please indicate your role preference: AI & Analytics Data Engineer, Visualization Engineer, or Data Scientist. AI & Analytics Data Engineer Responsibilities Integrate high-volume, high-variation, and/or high-velocity data to answers in real-time and enable clients to ask an entirely new class of questions. Deliver data pipelines to store data in a way that is accessible, performant, secure, and sustainable Prototype solutions, prepare test scripts, and conduct tests for data replication, extraction, loading, cleansing, and data modeling for data warehouses Review and validate data loaded into data lakes/warehouses for accuracy Develop proofs of concept and evaluate design options to deliver ingestion, search, metadata cataloging and scheduling of data pipelines for data modernization Data engineering in line with best practices and Cognizant's reference architecture Understand and document technical use case requirements in order to deliver data movement and transformation solutions Basic Qualifications Bachelor's degree in IT-related field and 0-3 years of IT experience Strong business communication skills (including written and oral) Experience with Java or Python development for modern data engineering Strong background in relational data models Exposure in ETL tools and Scala & Kafka Strong problem solving and analytical thinking skills Distinguishing Qualifications Full lifecycle development experience Implementation experience within the Hadoop ecosystem Industry experience (financial services, insurance, retail, healthcare, life sciences, communications) Experience leading teams Experience in developing and deploying distributed computing Big Data applications using Open Source frameworks such as Apache Spark Working knowledge of application development using Hadoop components (HDFS, HBase, Hive, Sqoop, Flume, etc.) Exposure to data analytics and data mining tools/applications such as Tableau, QlikSense /QlikView, R, or SAS Exposure to working with SQL, Relational Database Management Systems (e.g., SQL Server, Oracle) Development workflows (e.g., Microsoft VSTS) AI & Analytics Visualization Engineer Responsibilities Provide direct and interactive storytelling to clients through the use of information systems that transform data complexity into digitally-informed and intelligent data visualizations. Work with customers for addressing their visualization & narratives opportunities Frame and define strategic solution options to various stakeholders Perform analytical storytelling backed by self-developed visualizations and the articulation of IT-centric proposals to business communities Work with, and analyze, large data sets in multiple formats Embed AI within Visualization meaningfully to deliver customer outcomes R & D on new technologies and create shareable assets in the form of decks or whitepapers Basic Qualifications Master's degree in IT-related field and 0-3 years of IT experience Portfolio of exceptional visualizations including data contextualization Experience using Tableau or a comparable BI tool such as QlikView, Spotfire, D3, Looker, Jaspersoft, ThoughtSpot, Open Source Visualization tools Exposure to Data Engineering Fundamentals to deliver Visualization engagements successfully Strong problem solving and analytical thinking skills Distinguishing Qualifications Target to contribute on winning public hackathons Keep up-to-date on new analytics trends in the market, and identify where they can be implemented Focus on RPA, automation, innovations & tools, and track their benefit on RFP, project delivery Awareness of Narrative Science/ YSEOP/Automated Insights and concept of NLG/NLP etc. Big data monetization technologies including AtScale/Jethro/Arcadia data etc. Data Wrangling Technologies including Paxata/Trifacta/etc. AI & Analytics Data Scientist Responsibilities Provide context for data, business, and IT across the data management, business intelligence, and descriptive analytics domains to deliver better, faster, and smarter analytical insights to some of the world's most successful businesses - our clients. Build an in-depth understanding of the opportunity, challenge or issue domain, and its associated data Interact with large and impactful data sets across business functions Research, design, implement, and evaluate machine learning approaches and models Take the initiative in evaluating and adapting new approaches from data science research Investigate data visualization and summarization techniques for conveying key findings Communicate findings and obstacles to stakeholders to help drive the delivery to market Basic Qualifications Master's degree in IT-related or Engineering field and 0-3 years of IT experience Strong business communication skills (including written and oral) Hands-on experience in identifying and testing hypotheses, establishing correlations, selecting the right algorithms, building a predictive model using traditional, as well as machine learning algorithms, data quality assessment, imputing and transformation as well as familiarity with typical data distributions such as normal, binomials, chi-square, Poisson, etc. Hands-on experience with traditional modeling algorithms (e.g., regression, log-regression, clustering, Bayesian) Hands-on experience with the modeling platform like Python, R/R Studio Strong problem solving and analytical thinking skills Distinguishing Qualifications Ph.D. in IT-related or Engineering field and 0-3 years of IT experience Familiarity with machine learning algorithms (e.g., Extreme Gradient Boosting, SVM, Random Forest, Neural Networks, etc.) Familiarity with developing and deploying models in the Hadoop environment Experience with collaborative development workflows (e.g., Microsoft VSTS) Exposure to working with SQL, Relational Database Management Systems (e.g., SQL Server, Oracle) Learning & Development Your on-the-job success and Cognizant career advancement is important to us. To help you construct a platform for personal and professional growth, your Cognizant journey will include a learning program catering to your skill level and role. Gain niche Data Sciences skills vital to success in your new role Create job maneuverability in emerging and established technologies Our commitment to you Your innovative thinking and successes will be rewarded with opportunities for career advancement You can make a difference working with high-profile clients and projects You will be supported by a high-caliber analytics ecosystem New skills, knowledge, and training through our global network of experts Competitive salary including paid time off, a 401K matching program, an extensive healthcare benefits suite, and more Applicants must be willing to relocate - our business model requires our consultants to be as close to the client site as possible. Cognizant will provide relocation assistance. Cognizant will not sponsor H-1B or other U.S. work authorization, or lawful permanent residence (otherwise known as a "====") for this role. Cognizant is an equal opportunity employer provider and committed to creating a diverse environment. Cognizant considers all applicants without regard to race, creed, color..... click apply for full job details
Hunter Associates Laboratory, Inc.
Reston, Virginia
Summary of job: As the leader of the Engineering and New Product Development Team, this hands-on technical and leadership position works closely with other functional leaders in the company, including those in product management, production, service, sales, and marketing. This role is responsible for ensuring that the company's product offerings and underlying technologies lead the color measurement industry in innovation and value. Successful Candidate will have: Master's degree in an engineering discipline (preference for ME or EE) with 10+ years of experience in mechanical or electrical engineering, physics, optics or other related discipline, or PhD in physics or a relevant engineering discipline with 10+ years of experience. Minimum of 5 years' experience in the following areas: Demonstrable project management, Managing complex electro-optical product design projects, Performing under an ISO equivalent quality control program Managing small teams to accomplish a common goal. Certified Project Management Professional (PMP) desirable. Key responsibilities include: New Product Development and Introduction Provide informed technical and product vision and engineering leadership for existing and emerging products, platforms, and application technologies through an understanding of customer and business needs. Manage and ensure the optimal application of current technology, engineering resources, outsourced design services and project contractors to meet product development and/or customer requirements. Work closely with marketing and product management team to develop product specifications derived from market feedback, customer requirements gathering (voice of customer), and historical product data. Ensure product requirements are properly documented and understood by all stakeholders early in the product development process. Manage and support the overall design process; Check and approve design packages; Ensure that departmental work product meets company, legal, regulatory and business requirements; Implement appropriate functional engineering reviews as required. Work closely with procurement and materials management to identify qualified vendors to meet component and delivery capability requirements. Oversee prototype material procurement processes. Manage and oversee prototype development activities for new product designs utilizing the company's agile development approach while maintaining compliance to overall specifications; Promote effective production processes, ensure optimal performance and cost efficiency including manufacturability and serviceability. Oversee the creation and execution of design and instrument performance verification test plans; Manage the design and performance analysis process; Address issues such as failure, reliability, capacity, capability or instrument improvement. Oversee product design efforts to ensure that Industry Standards and Certifications, including CE and UL, are achieved. Ensure that new product designs are fully and correctly defined, documented and released per company standards. Engineering Management Provide hands-on project management, technical direction and guidance for all product and platform development programs as well as research activities. Generate periodic forecasts of engineering resource needs; Coordinate the deployment of design resources in line with agreed resource strategies; Identify appropriate design and engineering standards and practices to be used for departmental projects. Coordinate with project engineers and other project staff to ensure consistency in execution of project management activities. Oversee and review formal engineering documents such as Bills of Material (BOMs), Hardware Design Documents, Drawings, Specifications, Engineering Change Notifications / Engineering Deviation Notices (ECN / EDN), revision control, release documentation and design document packages; Conduct and oversee project design reviews and review Engineering Lab notebooks. Maintains safe and clean working environment by complying with procedures, rules, and regulations. Performs other duties as assigned. Leadership Lead a team of engineers in the definition, resourcing, implementation and delivery of electrical engineering work packages; Manage the entire electrical design, development, and testing program for current or new products. Lead engineering support to existing products, respond to outside vendor questions, and recommend product improvements. Investigate product issues from customers, evaluate problems, and recommend solutions in conjunction with other senior engineers. Drive the company's Quality Management System to conform to customer, internal, ISO 9001, and regulatory/legal requirements. Serve as a leader and advisor in the development of engineering solutions; Support the Vice President of Technology in effective design strategies and product / project planning. Manage, mentor, and develop a talented a team of multi-disciplinary engineers and related technical positions. Supervisory Responsibilities This position manages up to 10 engineers and other technical roles in the department and shares responsibility with the Vice President of Technology for the performance management and personnel development of those employees. ************************************************************************************************************************ While we sincerely appreciate all applications, only those candidates selected for an interview will be contacted. Please note the selected candidate will be required to submit to company background check. Interested to know more? Visit us at About HunterLab Driven by a life-long desire to help others, Richard Hunter became known as one of the world's foremost color scientists. A key accomplishment of his R&D career was the Theory of Opponent Colors, more widely known as Hunter Lab; today a cornerstone color scale throughout the entire color measurement industry. Now, we embrace his mission of helping others and provide world-class customer support and product innovation. HunterLab color measurement solutions are employed in a wide variety of industries including building materials, chemical, food, paint, paper, pharmaceutical, plastic, textile, and others. Our Associates enjoy an innovative, supportive and friendly work environment, great benefits including an Employee Stock Ownership Program, and a real opportunity to make a difference in science, technology, engineering, and math fields (STEM). Join our talented team of professionals and leaders. More than a job; it's an adventure in science with a global reach. What makes HunterLab a great place to work? At HunterLab, you will become an integral and respected part of the team. Our employees are known as "Associates" because we are all stakeholders in HunterLab's continued success. HunterLab is 100% employee owned! This is clearly conveyed through our excellent benefits package which includes health, dental, vision, flexible spending account, EAP, vacation leave, sick leave, paid holidays, parental leave, 401(k) including company match, education/tuition assistance, life insurance, disability insurance, Employee Stock Ownership Plan (ESOP) and company profit sharing. Our Associates are offered long-term growth and opportunity and are proud to be on our team. With over 60 years of experience in our industry, you will become part of an outstanding group of experts in our industry. We're also in walking distance to the Metro Silver Line! HUNTERLAB IS AN EQUAL OPPORTUNITY EMPLOYER We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. HunterLab participates in E-Verify. - provided by Dice
09/30/2020
Full time
Summary of job: As the leader of the Engineering and New Product Development Team, this hands-on technical and leadership position works closely with other functional leaders in the company, including those in product management, production, service, sales, and marketing. This role is responsible for ensuring that the company's product offerings and underlying technologies lead the color measurement industry in innovation and value. Successful Candidate will have: Master's degree in an engineering discipline (preference for ME or EE) with 10+ years of experience in mechanical or electrical engineering, physics, optics or other related discipline, or PhD in physics or a relevant engineering discipline with 10+ years of experience. Minimum of 5 years' experience in the following areas: Demonstrable project management, Managing complex electro-optical product design projects, Performing under an ISO equivalent quality control program Managing small teams to accomplish a common goal. Certified Project Management Professional (PMP) desirable. Key responsibilities include: New Product Development and Introduction Provide informed technical and product vision and engineering leadership for existing and emerging products, platforms, and application technologies through an understanding of customer and business needs. Manage and ensure the optimal application of current technology, engineering resources, outsourced design services and project contractors to meet product development and/or customer requirements. Work closely with marketing and product management team to develop product specifications derived from market feedback, customer requirements gathering (voice of customer), and historical product data. Ensure product requirements are properly documented and understood by all stakeholders early in the product development process. Manage and support the overall design process; Check and approve design packages; Ensure that departmental work product meets company, legal, regulatory and business requirements; Implement appropriate functional engineering reviews as required. Work closely with procurement and materials management to identify qualified vendors to meet component and delivery capability requirements. Oversee prototype material procurement processes. Manage and oversee prototype development activities for new product designs utilizing the company's agile development approach while maintaining compliance to overall specifications; Promote effective production processes, ensure optimal performance and cost efficiency including manufacturability and serviceability. Oversee the creation and execution of design and instrument performance verification test plans; Manage the design and performance analysis process; Address issues such as failure, reliability, capacity, capability or instrument improvement. Oversee product design efforts to ensure that Industry Standards and Certifications, including CE and UL, are achieved. Ensure that new product designs are fully and correctly defined, documented and released per company standards. Engineering Management Provide hands-on project management, technical direction and guidance for all product and platform development programs as well as research activities. Generate periodic forecasts of engineering resource needs; Coordinate the deployment of design resources in line with agreed resource strategies; Identify appropriate design and engineering standards and practices to be used for departmental projects. Coordinate with project engineers and other project staff to ensure consistency in execution of project management activities. Oversee and review formal engineering documents such as Bills of Material (BOMs), Hardware Design Documents, Drawings, Specifications, Engineering Change Notifications / Engineering Deviation Notices (ECN / EDN), revision control, release documentation and design document packages; Conduct and oversee project design reviews and review Engineering Lab notebooks. Maintains safe and clean working environment by complying with procedures, rules, and regulations. Performs other duties as assigned. Leadership Lead a team of engineers in the definition, resourcing, implementation and delivery of electrical engineering work packages; Manage the entire electrical design, development, and testing program for current or new products. Lead engineering support to existing products, respond to outside vendor questions, and recommend product improvements. Investigate product issues from customers, evaluate problems, and recommend solutions in conjunction with other senior engineers. Drive the company's Quality Management System to conform to customer, internal, ISO 9001, and regulatory/legal requirements. Serve as a leader and advisor in the development of engineering solutions; Support the Vice President of Technology in effective design strategies and product / project planning. Manage, mentor, and develop a talented a team of multi-disciplinary engineers and related technical positions. Supervisory Responsibilities This position manages up to 10 engineers and other technical roles in the department and shares responsibility with the Vice President of Technology for the performance management and personnel development of those employees. ************************************************************************************************************************ While we sincerely appreciate all applications, only those candidates selected for an interview will be contacted. Please note the selected candidate will be required to submit to company background check. Interested to know more? Visit us at About HunterLab Driven by a life-long desire to help others, Richard Hunter became known as one of the world's foremost color scientists. A key accomplishment of his R&D career was the Theory of Opponent Colors, more widely known as Hunter Lab; today a cornerstone color scale throughout the entire color measurement industry. Now, we embrace his mission of helping others and provide world-class customer support and product innovation. HunterLab color measurement solutions are employed in a wide variety of industries including building materials, chemical, food, paint, paper, pharmaceutical, plastic, textile, and others. Our Associates enjoy an innovative, supportive and friendly work environment, great benefits including an Employee Stock Ownership Program, and a real opportunity to make a difference in science, technology, engineering, and math fields (STEM). Join our talented team of professionals and leaders. More than a job; it's an adventure in science with a global reach. What makes HunterLab a great place to work? At HunterLab, you will become an integral and respected part of the team. Our employees are known as "Associates" because we are all stakeholders in HunterLab's continued success. HunterLab is 100% employee owned! This is clearly conveyed through our excellent benefits package which includes health, dental, vision, flexible spending account, EAP, vacation leave, sick leave, paid holidays, parental leave, 401(k) including company match, education/tuition assistance, life insurance, disability insurance, Employee Stock Ownership Plan (ESOP) and company profit sharing. Our Associates are offered long-term growth and opportunity and are proud to be on our team. With over 60 years of experience in our industry, you will become part of an outstanding group of experts in our industry. We're also in walking distance to the Metro Silver Line! HUNTERLAB IS AN EQUAL OPPORTUNITY EMPLOYER We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. HunterLab participates in E-Verify. - provided by Dice
7041 - CarMax Shockoe - 140 Virginia Street, Richmond, Virginia, 23219 CarMax, the way your career should be! Your expertise shapes our digital business At CarMax, we want to disrupt our industry by empowering customers to buy a car on their own terms - allowing them to transact with us anytime, anywhere. As a Senior developer, you'll be at the forefront of driving technical innovation alongside several product teams who are creating a seamless online transaction experience for our customers and associates. You are: Able to balance customer needs with business goals and know how to deliver technical solutions that enhance business value. Creative, curious and highly analytical, you never stop learning and thrive on constant change in the digital marketplace. From inception to completion, you will develop tools and technology, learning quickly from our spirit of experimentation. Overall, you will have a direct impact on improving the performance of our business and ensuring customers can buy the vehicles they want in a way that's right for them. We are: A team of experts (such as a Product Manager, Lead Developer, Delivery Manager, Analyst/Data Scientist, and other Software Developers), working in a fast-paced, highly collaborative, and customer-focused environment to bring a seamless online shopping experience to life. Together we'll be: A passionate technology team, developing ground-breaking products. Working collaboratively and creatively as part of a close-knit product team, you will be part of the development process from end to end: consulting users, carrying out experiments, tackling complex business problems and implementing new products. What you will do - Essential responsibilities Hands-on development to create and support new products and services that provide teams the ability to progress a customer through an online transaction As the online marketplace becomes the new dealership this position will be responsible for helping design new ways of collecting or creating media content Developing new solutions that include Integrating new hardware and software developed and designed by you Help design products that drive automation and business operations Collaborate with colleagues in product design, product management and systems architecture to develop experimental solutions and bring great ideas to life Market your new ideas internally and evolve them according to feedback and critique within an agile environment Stay on top of industry trends and best practice to continuously improve what we do and ensure our customer experience is the best it can be What technologies you'll be working with This role requires hands-on work in technologies such as JavaScript, ReactJS, Azure PaaS (Functions, App Services, App Insights, Redis, and others), .NET Core, TeamCity or Azure DevOps for CI/CD, Akamai edge, Javascript, React, load testing / automated testing tools like Selenium / Browserstack, Splunk, and API management systems. But more importantly at CarMax we are always learning so our tool set will evolve as you do. Qualifications and requirements At least eight years of application development experience Hands-on expertise with Microsoft.NET (#C) and .NET Core (or relevant experience) Hands-on expertise with Python, JS, & Akamai configuration Hands-on experience with DevOps capabilities such as automated testing, continuous integration, and continuous delivery Deep understanding of full-stack application design, including APIs, microservices, and front-end development (such as React, Angular, HTML/CSS, and other web design components) Proven experience working with technology teams to create and execute on an application architecture Knowledge of and experience with cloud computing platforms such as Azure or AWS highly preferred Exceptional communication skills, with experience presenting comfortably to and influencing technical teams, business users, and leadership Proven ability to mentor and develop others, as well as an ability to research and implement new technologies A degree in Computer Science or a related discipline or equivalent experience Upon an applicant's request, CarMax will consider reasonable accommodation to complete the CarMax Job Application .
09/29/2020
Full time
7041 - CarMax Shockoe - 140 Virginia Street, Richmond, Virginia, 23219 CarMax, the way your career should be! Your expertise shapes our digital business At CarMax, we want to disrupt our industry by empowering customers to buy a car on their own terms - allowing them to transact with us anytime, anywhere. As a Senior developer, you'll be at the forefront of driving technical innovation alongside several product teams who are creating a seamless online transaction experience for our customers and associates. You are: Able to balance customer needs with business goals and know how to deliver technical solutions that enhance business value. Creative, curious and highly analytical, you never stop learning and thrive on constant change in the digital marketplace. From inception to completion, you will develop tools and technology, learning quickly from our spirit of experimentation. Overall, you will have a direct impact on improving the performance of our business and ensuring customers can buy the vehicles they want in a way that's right for them. We are: A team of experts (such as a Product Manager, Lead Developer, Delivery Manager, Analyst/Data Scientist, and other Software Developers), working in a fast-paced, highly collaborative, and customer-focused environment to bring a seamless online shopping experience to life. Together we'll be: A passionate technology team, developing ground-breaking products. Working collaboratively and creatively as part of a close-knit product team, you will be part of the development process from end to end: consulting users, carrying out experiments, tackling complex business problems and implementing new products. What you will do - Essential responsibilities Hands-on development to create and support new products and services that provide teams the ability to progress a customer through an online transaction As the online marketplace becomes the new dealership this position will be responsible for helping design new ways of collecting or creating media content Developing new solutions that include Integrating new hardware and software developed and designed by you Help design products that drive automation and business operations Collaborate with colleagues in product design, product management and systems architecture to develop experimental solutions and bring great ideas to life Market your new ideas internally and evolve them according to feedback and critique within an agile environment Stay on top of industry trends and best practice to continuously improve what we do and ensure our customer experience is the best it can be What technologies you'll be working with This role requires hands-on work in technologies such as JavaScript, ReactJS, Azure PaaS (Functions, App Services, App Insights, Redis, and others), .NET Core, TeamCity or Azure DevOps for CI/CD, Akamai edge, Javascript, React, load testing / automated testing tools like Selenium / Browserstack, Splunk, and API management systems. But more importantly at CarMax we are always learning so our tool set will evolve as you do. Qualifications and requirements At least eight years of application development experience Hands-on expertise with Microsoft.NET (#C) and .NET Core (or relevant experience) Hands-on expertise with Python, JS, & Akamai configuration Hands-on experience with DevOps capabilities such as automated testing, continuous integration, and continuous delivery Deep understanding of full-stack application design, including APIs, microservices, and front-end development (such as React, Angular, HTML/CSS, and other web design components) Proven experience working with technology teams to create and execute on an application architecture Knowledge of and experience with cloud computing platforms such as Azure or AWS highly preferred Exceptional communication skills, with experience presenting comfortably to and influencing technical teams, business users, and leadership Proven ability to mentor and develop others, as well as an ability to research and implement new technologies A degree in Computer Science or a related discipline or equivalent experience Upon an applicant's request, CarMax will consider reasonable accommodation to complete the CarMax Job Application .