CMC Associate Director​/Director

Associate Director/Director, CMC (Late Stage Development, Bioprocess) 2-3 Days Per Week Onsite in Boston, MA Full-Time, Permanent

We are seeking an Associate Director/Director, CMC to provide technical and operational leadership for monoclonal antibody development and manufacturing across one or more programs. This role will help shape and execute phase-appropriate CMC strategies, with primary emphasis on drug substance process development, external manufacturing, and late-stage readiness.

The successful candidate will bring deep expertise in either upstream or downstream bioprocessing and sufficient breadth to integrate across drug substance, drug product, analytical, Quality, Regulatory, and Supply Chain interfaces. The individual will independently lead assigned CMC work streams, serve as a primary technical interface with CDMOs and partners, and translate complex data into clear recommendations for program teams and senior leadership.

This is an excellent next step for an experienced CMC or bioprocess professional who is ready to broaden from technical work into leading strategy, partners, and program decisions.

• Lead CMC strategy and execution for an assigned program or major work streams, integrating process, analytical, manufacturing, quality, regulatory, supply, timeline, and budget considerations.
• Provide technical leadership for upstream and/or downstream process development, scale-up and scale-down models, technology transfer, process characterization, and GMP manufacturing of monoclonal antibodies
• Lead late-stage process development, process characterization, and validation strategies through PPQ, including scale-down model qualification, study design, and process definition.
• Serve as the primary technical interface with CDMOs, overseeing plans, protocols, batch records, reports, campaign readiness, manufacturing execution, deliverables, and on-site support as needed.
• Review manufacturing and product-quality data to identify trends and risks; lead or support investigations, root-cause analysis, CAPAs, change controls, comparability assessments, and technical issue resolution.
• Translate process understanding into a robust control strategy, including CQAs, CPPs, operating ranges, sampling plans, acceptance criteria, and statistical approaches.
• Drive PPQ readiness and execution, author/review or approve supporting plans, risk assessments, protocols, and reports, and ensure an effective transition into continued process verification (CPV).
• Partner with Regulatory to author and review manufacturing and process sections of regulatory submissions, amendments, briefing packages, and responses to health-authority questions.
• Stay hands‑on and contribute across adjacent CMC and operational priorities as company and program needs evolve.

• 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: upstream or downstream focus and/or MSAT
• Deep expertise in upstream or downstream bioprocess development and/or MSAT, with enough 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 CDMOs 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, organized, detail‑oriented, and proven ability to lead cross‑functional work and influence without direct authority.

• We are a small, mission‑driven company, and success in this role depends as much on how the work gets done as on technical depth. We are looking for someone who:
• Collaborative—shares information early, actively seeks input, builds trust, and helps the team reach the…