We are seeking a highly experienced, motivated and team-oriented individual for a critical role in developing and registering the company’s pipeline of development-stage immuno-oncology biologics candidates. The successful candidate will provide technical leadership in developing a comprehensive process performance qualification (PPQ) strategy for biologics assets for commercial registration. The incumbent will lead the effort in defining the technical content of module 3 in BLA/MAA submission and approval. The successful candidate will define the strategy for biologics product life cycle management. The successful candidate will interact effectively and transparently with internal stakeholders in the areas of Biologics Analytical Development, Biologics Drug Product Development, CMC Project Management, Quality, Regulatory Affairs, Commercial Manufacturing and external CDMO business partners.
• Lead the effort in establishing a comprehensive biologics drug substance process performance qualification (PPQ) strategy for commercial registration.
• Responsible for establishing an integrated biologics drug substance control strategy.
• Review and/or approve PPQ protocols and PPQ reports by collaborating with quality, regulatory and external CDMO business partner.
• Collaborate with regulatory-CMC in defining technical content, related to drug substance, of module 3 for BLA/MAA submission.
• Lead the effort in authoring technical content of biologics drug substance module 3 of BLA/MAA and ensure timelines are met.
• Co-author and review responses to regulatory inquiry regarding BLA and MAA submissions.
• Responsible for meeting PMCs and/or PMRs.
• Lead effort in defining strategy for product life cycle management.
• Responsible for smooth transition of programs from development organization to commercial manufacturing organization.
• M.S. or Ph.D. in chemical/biochemical engineering, chemistry, biology, biochemistry, or related technical discipline.
• Minimum of 12 years’ (Ph.D.) and 15 years’ (M.S.) experience with 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, submission and approval.
• Hands-on working experience in biologics product life cycle management.
• Demonstrated track record of CDMO management in supporting manufacturing process development and GMP manufacturing.
• Approximately 15-25% domestic and international travel is anticipated.