Oregon State University
Corvallis, Oregon
Public Information Representative 1 Oregon State University Department: Chemistry (SCH) Appointment Type: Classified Staff Job Location: Corvallis Recommended Full-Time Salary Range: Job Summary: This recruitment will be used to fill one full-time Public Information Representative 1 position for the Department of Chemistry at Oregon State University (OSU). The purpose of this position is to carry out the public information program for the Department of Chemistry. This position works with administrative staff and faculty regarding public facing information, policy and procedural issues, and elevates issues as needed. In addition, the position serves as the primary media contact and events coordinator for the department. The OSU Department of Chemistry serves a central role to the educational, research and outreach missions of the University - delivering over 50,000 student credit hours of instruction each year while maintaining a vibrant graduate program with over 100 PhD students. The Department conducts cutting-edge research and scholarly activities focused on all areas of chemistry important to biology, materials and the environment - including analytical, biological, bio-organic, environmental, materials, nuclear and physical chemistry. This dynamic setting is ideally suited for nurturing and supporting instructional faculty in their efforts to support the Department's educational mission which impacts over 4000 students each year. The College of Science provides a core instructional role at OSU, supporting the ideals of learning, discovery, and engagement that are the foundation of a land-grant university. The College embraces instruction and research, in disciplines ranging from the physical to the biological sciences, that are based in unbiased inquiry and a dedication to discovery and innovation. The College of Science is committed to partnering with industry and public agencies to address some of the most compelling challenges of today and tomorrow. Why OSU? Working for Oregon State University is so much more than a job! Oregon State University is a dynamic community of dreamers, doers, problem-solvers and change-makers. We don't wait for challenges to present themselves - we seek them out and take them on. We welcome students, faculty and staff from every background and perspective into a community where everyone feels seen and heard. We have deep-rooted mindfulness for the natural world and all who depend on it, and together, we apply knowledge, tools and skills to build a better future for all. FACTS: • Top 1.4% university in the world • More research funding than all public universities in Oregon combined • 1 of 3 land, sea, space and sun grant universities in the U.S. • 2 campuses, 11 colleges, 12 experiment stations, and Extension programs in all 36 counties • 7 cultural resource centers that offer education, celebration and belonging for everyone • 100+ undergraduate degree programs, 80+ graduate degrees plus hundreds of minor options and certificates • 35k+ students including more than 2.3k international students and 10k students of color • 217k+ alumni worldwide • For more interesting facts about OSU visit: Locations: Oregon State has a statewide presence with campuses in Corvallis and Bend, the OSU Portland Center and the Hatfield Marine Science Center on the Pacific Coast in Newport. Oregon State's beautiful, historic and state-of-the-art main campus is located in one of America's best college towns. Corvallis is located close to the Pacific Ocean, the Cascade mountains and Oregon wine country. Nestled in the heart of the Willamette Valley, this beautiful city offers miles of mountain biking and hiking trails, a river perfect for boating or kayaking and an eclectic downtown featuring local cuisine, popular events and performances. Total Rewards Package: Oregon State University offers a comprehensive benefits package with benefits eligible positions that is designed to meet the needs of employees and their families including: • Medical, Dental, Vision and Basic Life. OSU pays 95% of premiums for you and your eligible dependents. • Free confidential mental health and emotional support services, and counseling resources. • Retirement savings paid by the university. • A generous paid leave package, including holidays, vacation and sick leave. • Tuition reduction benefits for you or your qualifying dependents at OSU or the additional six Oregon Public Universities. • Robust Work Life programs including Dual Career assistance resources, flexible work arrangements, a Family Resource Center, Affinity Groups and an Employee Assistance Program. • Optional lifestyle benefits such as pet, accident, and critical illness insurance, giving you peace of mind and the support you need to thrive in all aspects of your life. Future and current OSU employees can use the Benefits Calculator to learn more about the full value of the benefits provided at OSU. Key Responsibilities 60% PUBLIC RELATIONS and MEDIA: Develop and maintain the Department of Chemistry marketing materials including policies and procedures for social media accounts, website management, and media. Reviews media marketing plan with supervisor. Maintain a digital archiving system for all footage. Serve as primary news media contact for the department. Follow professional trends, keeping tools and practices current and accessible. Work with internal program areas to identify and serve unique needs and interests related to interactive media. Provides input to administration and faculty on planning and production of informational materials to ensure compliance with current and established laws, policy and protocol (specifically, OSU Branding Policy, ADA accessibility, Model Releases and Copyright Laws). Consult regularly with faculty and staff to keep all published content up-to-date and accurate. Set production deadlines and monitor progress to ensure completion of projects. Create web announcements, feature stories, web pages and web forms. Post collected information on department blog to be used in publications. Works with the dept. manager to design, write, edit and produce print publications such as newsletters, pamphlets, flyers, and news releases to promote departmental activities and programs. Publication would include but is not limited to articles on various lecture series, outreach activities, grants and awards given to faculty, and undergraduate and graduate students of the Quarter. Design, create and maintain photographic departmental directory for public view. Work closely with subcontractors for implementation and creation of final product. Coordinate with OSU Printing and Mailing and public entities for media and event related purchases (Michael's Craft Store, Fireline T's, etc.) Collaborate with faculty to write scripts for department events such as Fall Gathering and Spring Awards celebration. Serve as liaison with College of Science and campus marketing teams. Actively seek out department, college and university activities for possible publication and promotion. 30% - EVENT COORDINATION: Coordinate Department events including but not limited to meetings, seminars, celebrations, ceremonies and conferences. This would include travel/lodging, venue location and reservations, transportation, catering, and promotion. Obtain approvals as needed. Monitor Public Information budget to ensure compliance. Coordinate faculty visits for recruitment, seminars, conferences etc. Including arranging lodging, visitation schedule, transportation and catering. Assist with staff and faculty recruitment coordination; Work with search committee chair regarding application matrix use and process. 5% - Provide leadwork to 2 student employees. 5% - Other Duties as Assigned. Responsible for small purchases as needed for swag/ handouts at events What You Will Need . What We Would Like You to Have Excellent computer and video management skills. Experience developing and maintaining web pages. Three or more years of professional work experience in writing and producing marketing materials, presenting info to the public, or public relations experience. Demonstrated ability to engage with diverse audiences and promote access and inclusion to public events and programs. Working Conditions / Work Schedule Work in Departmental Administrative office Monday -Friday 7:30 am - 4:30 pm with 1 hour lunch break and 2 15-minute breaks. May require work outside the above hours to attend and record special events. Special Instructions to Applicants Applications will be reviewed based on the information submitted on the employment profile with education and work history along with any other requested documentation i.e. posting specific question responses, transcripts, etc. Your profile MUST clearly show how you meet the minimum/required qualifications for the position. Resumes are NOT accepted at the application stage for this position. Cover letters are optional for this position and will not be used for evaluating your qualifications. Equivalent required experience is based on full-time equivalent (40 hours per week). PLEASE NOTE: . click apply for full job details
Public Information Representative 1 Oregon State University Department: Chemistry (SCH) Appointment Type: Classified Staff Job Location: Corvallis Recommended Full-Time Salary Range: Job Summary: This recruitment will be used to fill one full-time Public Information Representative 1 position for the Department of Chemistry at Oregon State University (OSU). The purpose of this position is to carry out the public information program for the Department of Chemistry. This position works with administrative staff and faculty regarding public facing information, policy and procedural issues, and elevates issues as needed. In addition, the position serves as the primary media contact and events coordinator for the department. The OSU Department of Chemistry serves a central role to the educational, research and outreach missions of the University - delivering over 50,000 student credit hours of instruction each year while maintaining a vibrant graduate program with over 100 PhD students. The Department conducts cutting-edge research and scholarly activities focused on all areas of chemistry important to biology, materials and the environment - including analytical, biological, bio-organic, environmental, materials, nuclear and physical chemistry. This dynamic setting is ideally suited for nurturing and supporting instructional faculty in their efforts to support the Department's educational mission which impacts over 4000 students each year. The College of Science provides a core instructional role at OSU, supporting the ideals of learning, discovery, and engagement that are the foundation of a land-grant university. The College embraces instruction and research, in disciplines ranging from the physical to the biological sciences, that are based in unbiased inquiry and a dedication to discovery and innovation. The College of Science is committed to partnering with industry and public agencies to address some of the most compelling challenges of today and tomorrow. Why OSU? Working for Oregon State University is so much more than a job! Oregon State University is a dynamic community of dreamers, doers, problem-solvers and change-makers. We don't wait for challenges to present themselves - we seek them out and take them on. We welcome students, faculty and staff from every background and perspective into a community where everyone feels seen and heard. We have deep-rooted mindfulness for the natural world and all who depend on it, and together, we apply knowledge, tools and skills to build a better future for all. FACTS: • Top 1.4% university in the world • More research funding than all public universities in Oregon combined • 1 of 3 land, sea, space and sun grant universities in the U.S. • 2 campuses, 11 colleges, 12 experiment stations, and Extension programs in all 36 counties • 7 cultural resource centers that offer education, celebration and belonging for everyone • 100+ undergraduate degree programs, 80+ graduate degrees plus hundreds of minor options and certificates • 35k+ students including more than 2.3k international students and 10k students of color • 217k+ alumni worldwide • For more interesting facts about OSU visit: Locations: Oregon State has a statewide presence with campuses in Corvallis and Bend, the OSU Portland Center and the Hatfield Marine Science Center on the Pacific Coast in Newport. Oregon State's beautiful, historic and state-of-the-art main campus is located in one of America's best college towns. Corvallis is located close to the Pacific Ocean, the Cascade mountains and Oregon wine country. Nestled in the heart of the Willamette Valley, this beautiful city offers miles of mountain biking and hiking trails, a river perfect for boating or kayaking and an eclectic downtown featuring local cuisine, popular events and performances. Total Rewards Package: Oregon State University offers a comprehensive benefits package with benefits eligible positions that is designed to meet the needs of employees and their families including: • Medical, Dental, Vision and Basic Life. OSU pays 95% of premiums for you and your eligible dependents. • Free confidential mental health and emotional support services, and counseling resources. • Retirement savings paid by the university. • A generous paid leave package, including holidays, vacation and sick leave. • Tuition reduction benefits for you or your qualifying dependents at OSU or the additional six Oregon Public Universities. • Robust Work Life programs including Dual Career assistance resources, flexible work arrangements, a Family Resource Center, Affinity Groups and an Employee Assistance Program. • Optional lifestyle benefits such as pet, accident, and critical illness insurance, giving you peace of mind and the support you need to thrive in all aspects of your life. Future and current OSU employees can use the Benefits Calculator to learn more about the full value of the benefits provided at OSU. Key Responsibilities 60% PUBLIC RELATIONS and MEDIA: Develop and maintain the Department of Chemistry marketing materials including policies and procedures for social media accounts, website management, and media. Reviews media marketing plan with supervisor. Maintain a digital archiving system for all footage. Serve as primary news media contact for the department. Follow professional trends, keeping tools and practices current and accessible. Work with internal program areas to identify and serve unique needs and interests related to interactive media. Provides input to administration and faculty on planning and production of informational materials to ensure compliance with current and established laws, policy and protocol (specifically, OSU Branding Policy, ADA accessibility, Model Releases and Copyright Laws). Consult regularly with faculty and staff to keep all published content up-to-date and accurate. Set production deadlines and monitor progress to ensure completion of projects. Create web announcements, feature stories, web pages and web forms. Post collected information on department blog to be used in publications. Works with the dept. manager to design, write, edit and produce print publications such as newsletters, pamphlets, flyers, and news releases to promote departmental activities and programs. Publication would include but is not limited to articles on various lecture series, outreach activities, grants and awards given to faculty, and undergraduate and graduate students of the Quarter. Design, create and maintain photographic departmental directory for public view. Work closely with subcontractors for implementation and creation of final product. Coordinate with OSU Printing and Mailing and public entities for media and event related purchases (Michael's Craft Store, Fireline T's, etc.) Collaborate with faculty to write scripts for department events such as Fall Gathering and Spring Awards celebration. Serve as liaison with College of Science and campus marketing teams. Actively seek out department, college and university activities for possible publication and promotion. 30% - EVENT COORDINATION: Coordinate Department events including but not limited to meetings, seminars, celebrations, ceremonies and conferences. This would include travel/lodging, venue location and reservations, transportation, catering, and promotion. Obtain approvals as needed. Monitor Public Information budget to ensure compliance. Coordinate faculty visits for recruitment, seminars, conferences etc. Including arranging lodging, visitation schedule, transportation and catering. Assist with staff and faculty recruitment coordination; Work with search committee chair regarding application matrix use and process. 5% - Provide leadwork to 2 student employees. 5% - Other Duties as Assigned. Responsible for small purchases as needed for swag/ handouts at events What You Will Need . What We Would Like You to Have Excellent computer and video management skills. Experience developing and maintaining web pages. Three or more years of professional work experience in writing and producing marketing materials, presenting info to the public, or public relations experience. Demonstrated ability to engage with diverse audiences and promote access and inclusion to public events and programs. Working Conditions / Work Schedule Work in Departmental Administrative office Monday -Friday 7:30 am - 4:30 pm with 1 hour lunch break and 2 15-minute breaks. May require work outside the above hours to attend and record special events. Special Instructions to Applicants Applications will be reviewed based on the information submitted on the employment profile with education and work history along with any other requested documentation i.e. posting specific question responses, transcripts, etc. Your profile MUST clearly show how you meet the minimum/required qualifications for the position. Resumes are NOT accepted at the application stage for this position. Cover letters are optional for this position and will not be used for evaluating your qualifications. Equivalent required experience is based on full-time equivalent (40 hours per week). PLEASE NOTE: . click apply for full job details
University of Iowa Health Care
Iowa City, Iowa
The University of Iowa Hospitals and Clinics department of Radiology is seeking a Manufacturing Specialist to promote the University's research mission by supporting scientific, scholarly, and creative activities through scientific inquiry, open discovery, dissemination of new knowledge, administering programs, procedures and policies to assure compliance and to advance research, technology commercialization, or economic development. Individuals are responsible for the manufacturing of pharmaceuticals for internal (University) and external (hospitals and clinics, government, private) clients through compliance of FDA cGMP and ICH regulations and guidelines. Industry classifications include pharmaceutical manufacturing professionals and supervisors/managers in this area. Duties include: Compliance: • With oversight, maintain and document compliance with FDA regulations and safety procedures related to manufacturing, labeling, and inspection processes and equipment during their use within a sub-unit. • Follow regulations and procedures for handling and recording raw materials, including hazardous/regulated chemicals/radioactive materials. • When requested and with oversight, conduct and evaluate installation, operational, and performance qualification of equipment and instrumentation. • Assist in updating existing Standard Operating Procedures (SOPs). • Willingness to work in cGMP environment with radioactive materials and participate in safety programs designed to minimize potential and/or actual exposure levels. Manufacturing: • Conduct and oversee the setup, operation, cleaning and troubleshooting of manufacturing systems with a high degree of proficiency and produce cGMP grade radiopharmaceuticals. • Conduct Quality Control tests (e.g. TLC, GC, sterility) according to established SOPs on various radiopharmaceutical products. • Interact with clients as necessary and under supervision to assure their projects are completed in an appropriate manner. • Produce production run reports. • Perform release testing according to SOPs on other materials (e.g., raw materials for radiopharmaceutical production). • Must be able to work outside of regular work hours occasionally. Leadership: • Assure staff comply with federal and state regulations and SOPs. Participate in cross training to be able to perform functions across sub-unit boundaries. The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job. University of Iowa Hospitals & Clinics-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ® Percent of Time: 100% Qualifications - External Education Required: • A Bachelor's degree in Chemistry, Biology, or a science with emphasis on analytical chemistry or an equivalent combination of education and experience in a similar type of laboratory is required. Experience Required: • Experience 1- 3 years in laboratory techniques. • Excellent written and verbal communication skills are required. Desirable Qualifications: • Experience with the production of radiopharmaceuticals using automated synthesis units under cGMP environment is desired. • At least 1-3 year of experience in analytical or synthetic organic chemistry is desired. • Chromatographic analysis experience (HPLC, GC, TLC) is desired. • Computer-controlled instrumentation experience is desired. • Knowledge of analytical chemistry is desired. • Knowledge of radiochemistry synthesis and quality control procedures is desired. • Knowledge of safety procedures for working in a hazardous environment (chemical and radiological) is desired. • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification is desired. • Ability to multitask and coordinate parallel activities in a busy cGMP environment. • Working in a team environment. Benefits Highlights: • Regular salaried position. Located in Iowa City, Iowa • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans recblid j2gq88kznbpsf3km44o6kj5rhpqm84
The University of Iowa Hospitals and Clinics department of Radiology is seeking a Manufacturing Specialist to promote the University's research mission by supporting scientific, scholarly, and creative activities through scientific inquiry, open discovery, dissemination of new knowledge, administering programs, procedures and policies to assure compliance and to advance research, technology commercialization, or economic development. Individuals are responsible for the manufacturing of pharmaceuticals for internal (University) and external (hospitals and clinics, government, private) clients through compliance of FDA cGMP and ICH regulations and guidelines. Industry classifications include pharmaceutical manufacturing professionals and supervisors/managers in this area. Duties include: Compliance: • With oversight, maintain and document compliance with FDA regulations and safety procedures related to manufacturing, labeling, and inspection processes and equipment during their use within a sub-unit. • Follow regulations and procedures for handling and recording raw materials, including hazardous/regulated chemicals/radioactive materials. • When requested and with oversight, conduct and evaluate installation, operational, and performance qualification of equipment and instrumentation. • Assist in updating existing Standard Operating Procedures (SOPs). • Willingness to work in cGMP environment with radioactive materials and participate in safety programs designed to minimize potential and/or actual exposure levels. Manufacturing: • Conduct and oversee the setup, operation, cleaning and troubleshooting of manufacturing systems with a high degree of proficiency and produce cGMP grade radiopharmaceuticals. • Conduct Quality Control tests (e.g. TLC, GC, sterility) according to established SOPs on various radiopharmaceutical products. • Interact with clients as necessary and under supervision to assure their projects are completed in an appropriate manner. • Produce production run reports. • Perform release testing according to SOPs on other materials (e.g., raw materials for radiopharmaceutical production). • Must be able to work outside of regular work hours occasionally. Leadership: • Assure staff comply with federal and state regulations and SOPs. Participate in cross training to be able to perform functions across sub-unit boundaries. The information contained herein is not intended to be an exhaustive list of all responsibilities required of individuals performing this job. University of Iowa Hospitals & Clinics-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ® Percent of Time: 100% Qualifications - External Education Required: • A Bachelor's degree in Chemistry, Biology, or a science with emphasis on analytical chemistry or an equivalent combination of education and experience in a similar type of laboratory is required. Experience Required: • Experience 1- 3 years in laboratory techniques. • Excellent written and verbal communication skills are required. Desirable Qualifications: • Experience with the production of radiopharmaceuticals using automated synthesis units under cGMP environment is desired. • At least 1-3 year of experience in analytical or synthetic organic chemistry is desired. • Chromatographic analysis experience (HPLC, GC, TLC) is desired. • Computer-controlled instrumentation experience is desired. • Knowledge of analytical chemistry is desired. • Knowledge of radiochemistry synthesis and quality control procedures is desired. • Knowledge of safety procedures for working in a hazardous environment (chemical and radiological) is desired. • Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification is desired. • Ability to multitask and coordinate parallel activities in a busy cGMP environment. • Working in a team environment. Benefits Highlights: • Regular salaried position. Located in Iowa City, Iowa • Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans recblid j2gq88kznbpsf3km44o6kj5rhpqm84
Myovant Sciences
Brisbane, California
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Process Development and Manufacturing . The position reports to the Vice President, Pharmaceutical Operations and Development . The location of the position is in the Brisbane, CA. Summary Description The Director, Process Development and Manufacturing will lead the process chemistry and development for drug substance (API) spanning from discovery leads to support commercial production. The responsibilities include process development for new molecules and corresponding regulatory intermediates, identify CMOs to manufacture the APIs, carry out technology transfer to CMOs and manufacturing API following cGMP to meet portfolio needs, conduct scale up and technology transfer to support commercial supply needs. The individual will also be responsible for defining comprehensive control strategy to ensure quality API in a risk-based and phase appropriate manner, authoring drug substance CTD sections to support regulatory submission during clinical development and global registration and addressing health authority questions working with cross-functional team. He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the Process Development and Manufacturing function. The individual must have proven supervisory record and can work effectively at operational and governance levels in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. Essential Duties and Responsibilities Responsible for process development and manufacturing of drug substance (API), GMP starting materials and intermediates to enable clinical material manufacturing and process knowledge acquisition. Provide technical support for commercial production and responsible for technical transfer or scale up to ensure commercial supply. Delivery high-quality API requirements on time by applying a science-driven and risk-based API process development strategy Devise novel solutions and strategies to complex synthetic problems Identify and communicate risks and implement effective mitigation strategies by applying knowledge in process chemistry and overall drug development Have knowledge of GMP regulations, ICH guidance and current regulatory expectations Acquire key capabilities to support Myovant portfolio and products using innovative technologies Manage process budgetary, regulatory, and compliance systems within the framework of an internal and outsourced development and manufacturing business model. Continue to establish a comprehensive knowledge management system to capture critical raw data, process development activities, knowledge and to manage change control and regulatory submission Review, and/or approve Standard Operating Procedures, synthetic routes, regulatory filing, or other controlled documents as needed Serve on Pharmaceutical Operations & Development leadership team as well as cross-functional governance committee for organizational and technical decisions Participate in due diligence business development activities Perform other duties as assigned. Core Competencies, Knowledge, and Skill Requirements Thorough understanding of the product development and process development for late-stage clinical projects Proven track record of significant accomplishment in Process Development, including API production, GMP compliance, problem solving, novel idea generation and implementation and multi-step synthesis of complex molecular architecture Ability to prioritize, manage multiple tasks, and meet deadlines Ability to interpret and apply ICH guidance, cGMPs, USP, regulatory requirements and industry best practices Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction. Daily demonstrates a positive, 'can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks. Ability to multi-task and shift priorities quickly while working under tight deadlines. Skilled in developing collaborative internal and external relationships. Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary. Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders, employees and external partners Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company. Routinely interface with other functional areas, such as Analytical Development/ Quality Control, Pharmaceutical Technology, Quality Assurance, Regulatory, Supply Chain, Contract Manufacturing and external partners in a collaborative and effective manner Become a member of leadership team for Pharmaceutical Development & Manufacturing and participate in strategic decisions relating to project, organization, processes, budget and culture within the department REQUIREMENTS Education Doctorate degree from a leading institute in Synthetic Organic Chemistry, Chemical Engineering, Process Chemistry and related fields. Experience Requires 10+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment. Deep knowledge of modern process chemistry, process development, and practical experience with synthetic process development meeting safety, efficiency and environmental requirements, solid scientific knowledge of process chemistry, engineering and scale up A good understanding of the drug development process. Significant experience working in an outsourcing environment to support both clinical and commercial demand A strong track record of scientific achievements and effective ability to influence Candidates should have advanced problem solving skills, strategic thinking, process optimization experience and outstanding written and verbal communication skills Managerial responsibility of a small team TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT Regularly required to operate standard office equipment Ability to work on a computer for extended periods of time Regularly required to sit for long periods of time, and occasionally stand and walk Regularly required to use hands to operate computer and other office equipment Close vision required for computer usage Occasionally required to stoop, kneel, climb and lift up to 20 pounds Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. If you require any accommodations, please email . Equal Employment Opportunity
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women's health and prostate cancer designed to improve the lives of millions. We are on a mission to develop and deliver empowering medicines for women's health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission. We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Process Development and Manufacturing . The position reports to the Vice President, Pharmaceutical Operations and Development . The location of the position is in the Brisbane, CA. Summary Description The Director, Process Development and Manufacturing will lead the process chemistry and development for drug substance (API) spanning from discovery leads to support commercial production. The responsibilities include process development for new molecules and corresponding regulatory intermediates, identify CMOs to manufacture the APIs, carry out technology transfer to CMOs and manufacturing API following cGMP to meet portfolio needs, conduct scale up and technology transfer to support commercial supply needs. The individual will also be responsible for defining comprehensive control strategy to ensure quality API in a risk-based and phase appropriate manner, authoring drug substance CTD sections to support regulatory submission during clinical development and global registration and addressing health authority questions working with cross-functional team. He/She will provide strategic direction, tactical oversight and technical expertise for all activities within the Process Development and Manufacturing function. The individual must have proven supervisory record and can work effectively at operational and governance levels in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. Essential Duties and Responsibilities Responsible for process development and manufacturing of drug substance (API), GMP starting materials and intermediates to enable clinical material manufacturing and process knowledge acquisition. Provide technical support for commercial production and responsible for technical transfer or scale up to ensure commercial supply. Delivery high-quality API requirements on time by applying a science-driven and risk-based API process development strategy Devise novel solutions and strategies to complex synthetic problems Identify and communicate risks and implement effective mitigation strategies by applying knowledge in process chemistry and overall drug development Have knowledge of GMP regulations, ICH guidance and current regulatory expectations Acquire key capabilities to support Myovant portfolio and products using innovative technologies Manage process budgetary, regulatory, and compliance systems within the framework of an internal and outsourced development and manufacturing business model. Continue to establish a comprehensive knowledge management system to capture critical raw data, process development activities, knowledge and to manage change control and regulatory submission Review, and/or approve Standard Operating Procedures, synthetic routes, regulatory filing, or other controlled documents as needed Serve on Pharmaceutical Operations & Development leadership team as well as cross-functional governance committee for organizational and technical decisions Participate in due diligence business development activities Perform other duties as assigned. Core Competencies, Knowledge, and Skill Requirements Thorough understanding of the product development and process development for late-stage clinical projects Proven track record of significant accomplishment in Process Development, including API production, GMP compliance, problem solving, novel idea generation and implementation and multi-step synthesis of complex molecular architecture Ability to prioritize, manage multiple tasks, and meet deadlines Ability to interpret and apply ICH guidance, cGMPs, USP, regulatory requirements and industry best practices Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction. Daily demonstrates a positive, 'can do' and service oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy. Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks. Ability to multi-task and shift priorities quickly while working under tight deadlines. Skilled in developing collaborative internal and external relationships. Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary. Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders, employees and external partners Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company. Routinely interface with other functional areas, such as Analytical Development/ Quality Control, Pharmaceutical Technology, Quality Assurance, Regulatory, Supply Chain, Contract Manufacturing and external partners in a collaborative and effective manner Become a member of leadership team for Pharmaceutical Development & Manufacturing and participate in strategic decisions relating to project, organization, processes, budget and culture within the department REQUIREMENTS Education Doctorate degree from a leading institute in Synthetic Organic Chemistry, Chemical Engineering, Process Chemistry and related fields. Experience Requires 10+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment. Deep knowledge of modern process chemistry, process development, and practical experience with synthetic process development meeting safety, efficiency and environmental requirements, solid scientific knowledge of process chemistry, engineering and scale up A good understanding of the drug development process. Significant experience working in an outsourcing environment to support both clinical and commercial demand A strong track record of scientific achievements and effective ability to influence Candidates should have advanced problem solving skills, strategic thinking, process optimization experience and outstanding written and verbal communication skills Managerial responsibility of a small team TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT Regularly required to operate standard office equipment Ability to work on a computer for extended periods of time Regularly required to sit for long periods of time, and occasionally stand and walk Regularly required to use hands to operate computer and other office equipment Close vision required for computer usage Occasionally required to stoop, kneel, climb and lift up to 20 pounds Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. If you require any accommodations, please email . Equal Employment Opportunity
