Executive Director, Biologics CMC

We are seeking a highly accomplished CMC executive to lead biologics CMC strategy and external manufacturing operations across a growing portfolio of innovative biologic programs. You will serve as the Executive Director and CMC lead, providing strategic, technical, and operational oversight for end-to-end product development from early-stage development through commercialization. You will bring deep expertise in downstream process development, late-stage and commercial manufacturing readiness, and scalable manufacturing strategies to support future commercial success. This role places significant emphasis on downstream purification and process robustness, including chromatography development, filtration strategies, viral clearance, process characterization, PPQ readiness, and lifecycle management across all phases of development.

• Provide deep technical leadership in downstream purification operations, including chromatography (capture, intermediate, and polishing), filtration, and UF/DF. 
• Lead downstream process characterization, scale-up strategy, resin lifetime studies, and impurity clearance evaluations. 
• Troubleshoot purification performance issues such as aggregation, low yield, impurity breakthrough, or filtration bottlenecks. 
• Provide overall CMC leadership for assigned biologics programs, including bsAb and ADC molecules, from development through clinical and commercial manufacturing. 
• Oversee CDMO activities and serve as the primary technical and strategic interface between internal teams and external partners. 
• Deliver expert guidance on purification process design, optimization, and troubleshooting to ensure robust, scalable processes. 
• Monitor process development, MSAT, and manufacturing timelines to ensure timely, high-quality execution aligned with program goals and budgets. 
• Manage CDMO performance and proactively address technical or operational issues. 
• Coordinate with Quality, Regulatory, and Clinical functions to align CMC activities with development and regulatory strategies. 
• Prepare and review CMC sections of regulatory submissions (IND/IMPD/BLA). 
• Promote continuous improvement and ensure adherence to GMP, data integrity, and compliance requirements. 
• Support budgeting, vendor selection, and contract oversight for external manufacturing activities. 
• Provide technical leadership within a lean, collaborative team environment. 

• Ph.D. or M.S. in Biochemistry, Chemical Engineering, Biotechnology, or related field.
• Minimum 15+ years of industry experience in biologics process development, CMC leadership and GMP manufacturing, including extensive CDMO oversight.
• Demonstrated executive-level leadership experience advancing biologics programs from early development through commercialization.
• Deep expertise in downstream purification and commercial manufacturing of biologics; experience with upstream, formulation, and fill-finish operations is highly desirable.
• Extensive experience in late-stage and commercial manufacturing, including PC, PPQ, PAI readiness and lifecycle management.
• Demonstrated ability to lead CMC strategy and operations in a small or virtual biotech setting.
• Comprehensive knowledge of GMP, ICH guidelines, and regulatory expectations for biologics.
• Excellent communication, organizational, and problem-solving abilities.