What are the responsibilities and job description for the Director / Senior Director Drug Product Process Development position at Generation Bio?
SUMMARY:
Generation Bio seeks an energetic and highly motivated (Sr) Director to join our CMC team and lead the Drug Product Process Development team. This highly visible position will lead a team of scientists and engineers to drive process development and scale-up activities that enable GMP clinical production at external suppliers. The position will work closely with cross-functional colleagues in Research, Drug Product Process Science, Analytical Development, and Quality to deliver on the company objectives.
The successful candidate should have experience in LNP formulations and/or other forms of nanoparticle-based delivery systems as well as leading teams in a fast-paced environment. Additionally, the candidate should have experience with the technical and regulatory requirements to support clinical (GMP) manufacturing and technical transfer to CDMOs.
RESPONSIBILITIES:
- Lead and develop a team of scientists and engineers responsible for translating our platform drug product processes from research to clinical scale
- Work cross-functionally with early research and Drug Product Process Science to transfer, scale, and document manufacturing processes
- Accountable for establishing scalable, controlled, and robust manufacturing processes that support clinical production at external vendors
- Serve as a subject matter expertise to the Technical Operations team and CDMOs for clinical-scale manufacturing activities
- Define key manufacturing development strategies, including critical process parameters and critical quality attributes (CQAs) for the drug product
- Partner closely with the Analytical Development group to establish sampling and testing programs to achieve CQAs
- Establish, review, and approve process flow diagrams, development reports, and batch records.
- Create documents (scale-related development plans and reports, technical memos and protocols, etc.) related to CMC production and testing to support regulatory filings.
- Identify opportunities to improve systems and practices, and drive harmonization across manufacturing platform
QUALIFICATIONS:
- Ph.D. in Biochemistry, Chemistry, Chemical Engineering, or equivalent with a minimum of 6 years of relevant experience. M.Sc. with a minimum of 12 years relevant experience.
- Broad background in nanoparticle-based delivery systems, experience with LNP process development and technologies
- Knowledge of GxP regulations and QbD principles
- Experience leading and developing a team of scientists and engineers
- Experience supporting external vendors/contract organizations in a GxP setting
- Experience authoring regulatory submissions and responses strongly preferred
- Strong verbal and written communication skills, detail-oriented, exceptionally organized, and possesses the ability to influence change across different stakeholder groups
- Ability to drive decisions and achieve consensus with internal stakeholders including DP Process Science, Technical Operations, Analytical Development, and Quality
- Ability to work in a cross-functional, matrix-managed format, challenge others and be challenged
- Ability to diversify technical skillsets in a fast-paced organization
- Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes
POSITION: Full-Time, Exempt
