Associate Director, Drug Product Development
$177k/y-$235k/y
Formation Bio3 days ago
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HybridFull-timeSenior
Summary
Formation Bio is seeking an Associate Director, Drug Product Development to join their team in New York, NY. The role involves providing strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, focusing on sterile injectables.
About the Role
As the Associate Director, Drug Product, you will oversee formulation development, fill-finish, packaging, and release of drug products at CDMOs, ensuring alignment with program timelines, quality standards, and regulatory requirements. You will lead drug product manufacturing strategy from preclinical through commercial stages, serve as the primary technical interface with CDMOs, and ensure compliance with cGMP regulations. Your responsibilities will also include managing relationships with manufacturing partners, supporting scale-up activities, and authoring CMC sections of regulatory submissions.
About You
Required:
- MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
- 6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug product manufacturing, formulation development, and fill-finish operations.
- Demonstrated track record of managing drug product manufacturing campaigns for biologics from preclinical through late-stage clinical or commercial manufacturing.
- Strong knowledge of cGMP regulations, FDA and EMA guidelines, and ICH quality guidelines.
Preferred:
- Technical expertise in aseptic fill-finish operations, lyophilization processes, and drug product characterization for biologics.
- Experience authoring and reviewing CMC sections of regulatory submissions related to drug product manufacturing.
- Strong project management skills with the ability to manage multiple manufacturing programs simultaneously.
Benefits
- Competitive compensation with a salary range of $177k–$235k.
- Equity options and comprehensive benefits package including health coverage.
- Generous perks and hybrid work flexibility.
Formation Bio
Formation Bio is a tech-driven pharmaceutical company differentiated by radically more efficient drug development. Formation Bio has built a technology platform that optimizes critical aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies with the goal to develop them faster in order to accelerate access to new treatments for patients, and to unlock greater value per program.
New York, NY