Associate Director, Biologics, CMC

Associate Director, Biologics CMC

The Associate Director, Biologics CMC is a technical contributor responsible for supporting biologics development from upstream cell culture and process development through drug product readiness, clinical supply, and regulatory submission. This role provides technical input for large molecule programs, including monoclonal antibodies, fusion proteins, and related biologic modalities, while partnering closely with Process Development, Analytical Development, Quality, Regulatory, Clinical Operations, and external CDMOs.

Work Arrangement & Location

Hybrid

Essential Duties and Responsibilities

·       Support biologics CMC development activities with emphasis on upstream cell culture, process development, scale-up, technology transfer, and drug product readiness.

·       Provide technical input for mammalian cell culture processes, including cell line performance, media and feed strategy, bioreactor operation, process characterization, and troubleshooting.

·       Contribute to formulation, fill-finish, container-closure, stability, compatibility, and clinical supply activities in collaboration with drug product and analytical teams.

·       Provide day-to-day technical oversight of CDMO activities for upstream process development, GMP manufacturing support, change control, deviation investigations, and technical documentation.

·       Prepare and review CMC sections of regulatory submissions and support responses to health authority questions related to upstream process and drug product topics.

·       Apply DoE, process characterization, and risk management principles to support phase-appropriate development decisions.

Qualifications

·       Ph.D. or M.S. in Chemical Engineering, Biochemical Engineering, Cell Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline; equivalent experience may be considered.

·       8 years of biologics CMC experience, with strong technical expertise in upstream cell culture and mammalian process development.

·       Hands-on experience with fed-batch cell culture processes, bioreactor scale-up, process characterization, technology transfer, and GMP manufacturing support.

·       Experience working with biologics CDMOs, including technical support for upstream process development, GMP production, deviation investigations, and process performance monitoring.

·       Working knowledge of biologics formulation, fill-finish, stability, and drug product development sufficient to support integrated CMC execution.

·       Knowledge of ICH, FDA, and EMA expectations for biologics CMC development and regulatory submissions.

·       Ability to work cross-functionally, communicate complex technical issues clearly, and operate effectively in a fast-paced, resource-constrained environment.