An industry-leading biopharmaceutical company is looking for a Director of Drug Product Technical Operations to manage critical manufacturing operations for CNS therapies. This role involves managing external manufacturing partnerships, overseeing technology transfer, and leading process validation for commercial products, with cross-functional collaboration across CMC, supply chain, quality, and regulatory functions.
Key Responsibilities:
- Develop and implement strategic plans for drug product manufacturing to support commercial and regulatory submission goals.
- Lead formulation, process development, scale-up, and technology transfer to ensure robust commercial manufacturing.
- Oversee process validation, from protocol development to execution and detailed report preparation.
- Drive efficient technology transfer between R&D and manufacturing facilities, both domestically and internationally.
Qualifications:
- Advanced degree (Ph.D., M.Sc., or equivalent) in Pharmaceutical Sciences, Chemical Engineering, or related field.
- 10+ years in commercial drug product manufacturing, with at least 7 years in oral solid dose production.
- Proven experience in CMO management, tech transfer, scale-up, and validation processes.
- Strong knowledge of FDA regulations, ICH guidelines, and compliance in commercial drug manufacturing.
- Proficiency in statistical software (e.g., JMP, Minitab) for process optimization and validation.
