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Posted a day ago
Associate Director/Director, Technical Operations - Drug Substance (Small Molecules)
Axsome TherapeuticsAssociate Director/Director, Technical Operations - Drug Substance (Small Molecules)
Requirements
BS, MS, or PhD in Chemical Engineering, Chemistry, or related field, 6-8+ years experience (MS/PhD) or 10+ years (BS) in drug substance manufacturing, Experience with commercial drug substance manufacturing and process validation, Ability to work on-site in NYC 3 days per week
Skills
GMP
About the role
Responsibilities
- Lead and support day-to-day technical operations for commercial drug substance manufacturing in compliance with cGMP, FDA, EMA, and ICH guidelines
- Prepare, review, and approve technology transfer documentation, validation protocols, and final reports
- Provide technical leadership for process performance qualification (PPQ), scale-up activities, and manufacturing readiness
- Develop, review, and maintain Continued Process Verification (CPV) programs using statistical trending and control charting
- Lead investigations related to OOS/OOT results, deviations, and non-conformances, including root cause analysis and CAPA implementation
- Perform risk assessments and develop mitigation strategies for process changes and equipment modifications
- Author and review Module 3 sections of regulatory submissions
- Provide technical oversight and management of external CDMOs
Requirements
- BS, MS, or PhD in Chemical Engineering, Chemistry, or a related technical discipline
- MS or PhD with 6–8+ years of experience in pharmaceutical drug substance manufacturing, MSAT, or technical services
- OR Bachelor’s degree with 10+ years of experience in small-molecule drug substance manufacturing or technical operations
- Demonstrated hands-on experience supporting commercial drug substance manufacturing and process validation
- Ability to work on-site in New York City at least three days per week
- Willingness to travel periodically as required
Preferred Qualifications
- Pre-approval process development experience
- Solid-state chemistry and particle engineering experience
- Experience with unit operation modeling and process simulation tools
- Proficiency with statistical software for process monitoring and trending
About the Company
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions, focusing on novel mechanisms of action to improve patient outcomes in neuroscience.
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Get started — it's freeAssociate Director/Director, Technical Operations - Drug Substance (Small Molecules)
Axsome Therapeutics · New York
