Director / Senior Director, Biologics CMC

Role Summary

We are seeking an experienced CMC leader to oversee GMP development and manufacturing activities for biologics executed at external CDMOs. This individual will serve as the program CMC lead, directing end-to-end process and manufacturing strategy, execution, and compliance across all development phases. The ideal candidate must possess strong technical expertise in downstream protein purification, complemented by demonstrated program management and vendor oversight experience. This role emphasizes downstream purification, including chromatography development, filtration strategies, viral clearance, and UF/DF process robustness across all phases.

Responsibilities

• 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.

Qualifications

• Minimum 10 years of industry experience in biologics process development and GMP manufacturing, including substantial CDMO oversight.
• Strong expertise in purification/downstream process development; experience in upstream, formulation, or fill-finish is desirable.
• Extensive experience in late-stage and commercial manufacturing, including PC, PPQ, and PAI readiness.
• 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.
• Strong communication, organizational, and problem-solving abilities.

Education

• Ph.D. or M.S. in Biochemistry, Chemical Engineering, Biotechnology, or related field.