Associate Director, Technical Operations, Biologics Drug Substance Manufacturing

Position Summary

The Associate Director, Technical Operations, Biologics Drug Substance Manufacturing is responsible for providing technical expertise and operational leadership and support for biologic drug substance manufacturing from late-stage clinical development through commercialization. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory Affairs on manufacturing processes and validation activities of a biologics product at external Contract Development and Manufacturing Organizations (CDMOs).

The ideal candidate will have deep technical expertise in microbial fermentation, with a focus on downstream production, with demonstrated experience supporting late-stage development, Process Performance Qualification (PPQ), and Biologics License Application (BLA) submissions.

• Provide technical oversight for drug substance manufacturing activities supporting late-stage clinical and commercial biologics programs at company CDMOs. The focus will be on downstream production.
• Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization (PC) and PPQ protocols and reports.
• Serve as technical resource for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
• Monitor process performance data, identify process trends, and recommend improvements to increase process robustness, product quality, and manufacturing efficiency.
• Support tech transfer and process scale-up at CDMOs.
• Partner with Regulatory Affairs to prepare technical documentation supporting CMC sections of IND, BLA, and regulatory agency responses.
• Author technical reports on a variety of manufacturing related subjects.
• Support lifecycle management activities, including process optimization, post-approval changes, and continued process verification (CPV).
• Additional duties assigned as needed.

• Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required. Equivalent combination of education and applicable job experience may be considered. Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred.
• 8+ years of relevant experience including biologics manufacturing, scale-up, and late stage drug development and commercialization.

• Strong technical expertise in microbial fermentation and downstream processing for recombinant proteins or other biologic products is necessary. Experience in PEGylation is a plus.
• Demonstrated experience supporting late-stage clinical development through commercial manufacturing.
• Direct experience with QbD and supporting PPQ and process validation activities.
• Experience preparing or supporting the CMC manufacturing sections of Biologics License Applications (BLA).
• Broad knowledge of US and EU cGMP regulations, FDA and ICH guidance, technology transfer, process validation, and lifecycle management.
• Experience working with external CDMOs, including oversight of manufacturing campaigns and technical issue resolution.
• Working knowledge of statistical process monitoring, process characterization, and quality risk management tools.
• Experience interpreting manufacturing data, troubleshooting process issues, and implementing scientifically sound solutions.
• Excellent technical writing and documentation skills, including preparation of protocols, reports, investigations, and regulatory documentation.
• Strong interpersonal and organizational skills and exceptional communication skills are required.
• Ability to travel 20%-25% domestically and internationally.