Associate Director, Drug Product Manufacturing

Primary Responsibilities Include

• Lead clinical and commercial drug product manufacturing activities for large molecule, sterile injectable programs (liquid and lyophilized)
• Serve as the primary technical owner for drug product manufacturing at CDMOs, providing strategic direction and hands-on oversight across clinical campaigns from pre-IND through commercial
• Drive day-to-day manufacturing activities, including preparation and review of batch records and process documentation
• Maintain on-site presence at CDMOs during manufacturing campaigns to ensure execution quality and provide real-time technical guidance
• Oversee batch disposition activities in collaboration with Quality Assurance

Manufacturing Operations & Continuous Improvement

• Lead investigation and resolution of manufacturing deviations, process failures, and yield issues
• Author and review deviation reports, investigations, CAPAs, and change controls
• Identify and implement process improvements through change control and validation activities
• Evaluate new manufacturing technologies with a focus on scalability and robustness

Tech Transfer & Development Support

• Drive tech transfer activities for internal and external manufacturing partners, including development of plans, instructions, and risk assessments
• Partner with internal and external teams on process development and characterization to support regulatory submissions (IND/IMPD, BLA/MAA)
• Ensure manufacturing processes are aligned with clinical and commercial needs

Cross-Functional Collaboration & Compliance

• Represent drug product manufacturing on cross-functional teams, communicating program status, risks, and mitigation strategies
• Partner closely with QA to ensure all GMP activities align with internal quality systems and regulatory expectations
• Collaborate with supply chain to ensure clinical supply continuity and planning execution
• Author and review technical reports and regulatory submission sections related to drug product

Education and Skills Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline; advanced degree preferred
• 8+ years (BS) or 3+ years (MS) of relevant drug product manufacturing experience
• Experience in parenteral drug product manufacturing with CDMO oversight
• Strong knowledge of sterile manufacturing and fill-finish operations
• Experience with batch records, deviations, and tech transfer
• Deep understanding of cGMP and regulatory expectations (FDA, EMA)
• Strong troubleshooting and problem-solving capabilities
• Effective cross-functional collaboration skills
• Strong written and verbal communication skills
• Ability to manage multiple programs in a fast-paced environment