• Coordinate the effort in establishing an integrated biologics drug substance control strategy.
• Author and review PPQ protocols and PPQ reports by collaborating with quality, regulatory and external CDMO business partner.
• Manage and oversee PPQ related activities at CDMO sites.
• Participate in process characterization, process tech transfer, process scale-up, and onsite GMP manufacturing support.
• Collaborate with regulatory-CMC and assist in defining technical content, related to drug substance, of module 3 for BLA/MAA submission.
• Author and review technical content of biologics drug substance module 3 of BLA/MAA.
• Serve as a subject-matter expert on process support during regulatory agency inspections. Coauthor and review responses to regulatory inquiry regarding BLA and MAA submissions.
• Ensure the smooth transition of programs from development organization to commercial manufacturing organization.
• Assist in CDMO selection, management and auditing, as needed.
• M.S. or Ph.D. in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline.
• Minimum of 8 years (Ph.D.) or 12 years (M.S.) of experience in biologics drug substance development.
• Demonstrated track record of leading and managing late-stage biologics drug substance process development, process characterization, process performance qualification activities.
• Hands-on working experience in BLA/MAA authoring and submission.
• Strong knowledge of CMC regulatory requirements from IND filing to BLA/MAA submission.
• Demonstrated track record of CDMO management in supporting manufacturing process development and GMP manufacturing.
• Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
• Approximately 15-25% domestic and international travel is anticipated.