Lead the operational oversite of clinical external manufacturing (CMO) of Drug Product
Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products
Experience managing CMOs and technology transfer of processes to external Contract Manufacturing Organizations
Ensure strict adherence to cGMP requirements and global health authority expectations regarding aseptic controls
Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations
Execute risk assessments and define process control strategies using QbD principles
Troubleshoot manufacturing issues, analyze data, and implement process improvements
Lead deviation investigations, CAPAs, and change controls
Review CMC sections for regulatory submissions including INDs, IMPDs, and BLAs
Serve as a Subject Matter Expert during regulatory agency interactions
Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines

Bachelor of Science and 12 years or Master’s and 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related scientific discipline
10+ years’ experience in drug product CMC support.
Up to 5-10% of travel is required
Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing.
Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs for commercialization.
Proven track record as a people leader with strong cross-functional communication and strategic problem-solving abilities.

Associate Director/Director, Drug Product, CMC

Key skills