CMC Director

Associate Director/Director, CMC (Late Stage Development, Bioprocess)

Summary:

Seeking an experienced professional to provide technical and operational leadership for monoclonal antibody development and manufacturing, focusing on late-stage CMC strategies, process development, and external manufacturing. This role requires expertise in bioprocessing and the ability to integrate across multiple CMC functions, lead workstreams, and serve as a technical interface with external partners.

Responsibilities:

• Lead CMC strategy and execution for assigned programs, integrating process, analytical, manufacturing, quality, regulatory, supply, timeline, and budget considerations.
• Provide technical leadership for upstream and/or downstream process development, scale-up/scale-down models, technology transfer, process characterization, and GMP manufacturing of monoclonal antibodies.
• Drive late-stage process development, process characterization, and validation strategies through PPQ, including study design and process definition.
• Act as the primary technical interface with external manufacturing organizations, overseeing plans, protocols, batch records, reports, and campaign readiness.
• Review manufacturing and product-quality data to identify trends and risks; lead or support investigations, root-cause analysis, CAPAs, change controls, and technical issue resolution.
• Translate process understanding into robust control strategies, including CQAs, CPPs, operating ranges, sampling plans, and statistical approaches.
• Drive PPQ readiness and execution, author/review supporting plans, risk assessments, protocols, and reports, ensuring effective transition into continued process verification (CPV).
• Collaborate with regulatory teams to author and review manufacturing and process sections of regulatory submissions, amendments, and responses to health authority questions.

Qualifications:

• Bachelor’s, Master’s, or Ph.D. in chemical or biochemical engineering, biotechnology, biochemistry, pharmaceutical sciences, or a related discipline.
• 10+ years of progressively responsible experience in biologics process development/technical operations, with upstream or downstream focus and/or MSAT.
• Deep expertise in upstream or downstream bioprocess development and/or MSAT, with breadth to work across analytical, formulation, and drug product.
• Direct late-stage experience supporting process characterization, technology transfer, PPQ readiness or execution, and CPV for a biologic program.
• Demonstrated experience overseeing external manufacturing organizations and GMP manufacturing activities, including technical documentation, issue resolution, and risk management.
• Strong working knowledge of QbD, DoE, process validation lifecycle principles, control strategies, quality risk management, and applicable FDA/EMA/ICH expectations.
• Strong scientific judgment, technical writing, communication, organizational skills, detail orientation, and proven ability to lead cross-functional work and influence without direct authority.
• Collaborative, proactive, highly organized, detail-oriented, and able to communicate with clarity and respect across teams.
• Comfortable moving between strategy and hands-on execution, and able to contribute beyond primary specialty as priorities shift.