About Us
About the Role
The Associate Director/Director of Drug Product CMC will lead the operational oversite of clinical external manufacturing (CMO) of Drug Product required to transition monoclonal antibodies (mAbs) and biotherapeutics into scalable, robust processes from Drug Substance to Drug Product stage. This role heavily centers on a solid understanding of Protein Chemistry, optimizing formulation and process parameters, overcoming shear stress and aggregation, and advancing prefilled syringe (PFS) and combination product delivery systems from late-stage clinical development, process performance qualification through commercial launch. This role will partner with Quality, Supply Chain, External Manufacturing and Regulatory CMC to manage technical risk and maintain continuity of product and process knowledge across external manufacturing networks.
This is a unique opportunity to join a growing organization with an expanding pipeline, and to play an integral role in the global development of all programs. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products (liquid and lyophilized) in vial and prefilled syringe formats.
- Experience managing CMOs and technology transfer of processes to external Contract Manufacturing Organizations (CDMOs).
- Develop a robust manufacturing process based on sound knowledge of the functionality of vial/PFS Fillers, Isolators, RABS, Sterilizers and other ancillary equipment.
- Ensure strict adherence to cGMP requirements and global health authority expectations (FDA, EMA) regarding aseptic controls.
- Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations that minimize protein aggregation.
- Execute risk assessments (e.g., FMEA) and define process control strategies using QbD principles.
- Troubleshoot manufacturing issues, analyze data, and implement process improvements through life cycle management of Drug Product. .
- Lead deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls.
- Review CMC sections (Module 3) for regulatory submissions including INDs, IMPDs, and BLAs.
- Serve as a Subject Matter Expert (SME) during regulatory agency interactions, audits, and pre-approval inspections (PAI)
- Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines
- Functional knowledge of analytical instruments is preferred but is not required.
Experience
- 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 (Restricted Access Barrier Systems) 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.