Director of Bioassay/Immunoassay; Commercial Methods Lifecycle
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
The primary role of the Director, Bioassay/Immunoassay and Commercial methods lifecycle is to provide leadership to the analytical sciences and technology (AST) team to enable achievement of its mission of delivering the analytical CMC strategy required for licensure and support of the commercial product lifecycle. As a Director you will lead a team of scientists responsible for the lifecycle of bioassays, potency assays, and immunoassays required for release and stability testing of commercial products. Specifically you will provide strategic and technical guidance to facilitate achievement of the teams’ deliverables which include; methods validation, methods transfer, methods troubleshooting, serving as method subject matter experts, method performance monitoring, critical reagent management and authoring/reviewing regulatory submissions.
As a member of the analytical sciences and technology leadership team, you will contribute to developing the overarching strategy and tactics required to achieve AST deliverables. Analytical Sciences and Technology resides within the manufacturing sciences, and biologics development and operations organization. AST is responsible for delivering the analytical CMC strategy from late stage development throughout the product lifecycle for an array of biopharmaceutical modalities.
- Functions as a technical leader of a group of scientists with a broad range of bioassay/immunoassay experience (binding ELISA, potency ELISA, cell-based bioassays, HCP/rProtA ELISAs, DNA assays).
- As a member of the AST leadership team partners across AST and the manufacturing sciences and technology organization to deliver the overarching CMC strategy required for advancement of projects from process validation to licensure, and maintenance of products throughout the commercial lifecycle. This includes enabling process enhancements, providing troubleshooting guidance for manufacturing and quality control testing across the global network, and partnering with global regulatory sciences on strategy for global filings.
- Assists scientists in the design of experiments and review/interpretation of data.
- Establishes globally compliant strategies for methods validation and transfer.
- Contributes to regulatory strategy for bioassay/immunoassay control strategies (including specifications, reference standards, etc).
- Accountable for monitoring performance of bioassays/immunoassays across global testing network and partnering with QC labs to troubleshoot assays as needed.
- Authors and reviews regulatory submissions from licensure throughout product lifecycle (rest of world submissions).
- Manages performance and career development of a group of colleagues.
Specific Knowledge, Skills, Abilities, etc\:
- Experience developing and maintaining the analytics required for the development and licensure of biopharmaceuticals.
- Demonstrated expertise in developing, executing, and troubleshooting assays used to test and characterize biological products (binding ELISA, potency ELISA, cell-based bioassays, qPCR).
- Demonstrated experience setting strategies for methods validation that are aligned with industry best practices and meet global health authority requirements.
- Experience applying an array of statistical tools to analyze data, interpret trends, set specifications, define testing strategy (sample number).
- Familiarity with regulatory guidelines and cGMP laboratory processes.
- Experience authoring and/or reviewing regulatory submissions.
- PhD in biological sciences, chemistry or related scientific disciplines with > 10 yrs. relevant experience.
- MS or BS with > 15 yrs relevant experience.
- Industry experience in analytics required for licensure and lifecycle management of Biopharmaceuticals.
- This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the following\:
- Sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment.
- This role requires office work, teleconferencing, computer work, leading meetings and thus involves the following\:
- Working in open office environment, working in laboratory, working alone, working with/around others.
- This position may require approximately 20% travel.
- Requires supervisor duties
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.