Senior Director of Drug Product CMC (Biologics)
EPM Scientific are partnered with a leading organization who are seeking a proven Senior Director of Drug Product CMC to build and lead end‑to‑end biologics drug product strategy-from early development through PPQ and commercial launch. You'll own formulation and process development, aseptic/fill‑finish, combination‑product interfaces, and CDMO governance to deliver robust, compliant, and inspection‑ready outcomes for a biologics pipeline that includes several protein therapeutics.
Key Responsibilities
- Define and drive the global Drug Product CMC strategy across programs, aligning development, manufacturing, and regulatory milestones from IND to BLA.
- Lead formulation and process development for biologics, including container‑closure selection/qualification, aseptic operations, and sterile fill‑finish readiness.
- Oversee technology transfer, scale‑up, and PPQ at CDMOs; ensure data packages and facilities are inspection‑ready for health authority reviews.
- Provide strong CDMO/CMO governance, issue escalation/triage, and phase‑appropriate controls; apply formal risk management (ICH Q9) and continuous improvement.
- Partner closely with Quality, Regulatory, Supply Chain, and Process/MS&T to maintain compliant execution and on‑time delivery.
- Guide device/combination‑product interfaces (e.g., PFS/autoinjectors), human factors touchpoints, and lifecycle decisions impacting DP.
- Build, mentor, and develop a high‑performing team and a scalable operating model for Boston growth.
Qualifications
- Ph.D. (preferred) or M.S./B.S. in Chemical Engineering, Pharmaceutics, or related field with 15+ years in biologics Drug Product CMC.
- Demonstrated success taking biologics DP from clinical through commercial, including tech transfer, PPQ/process validation, and launch readiness.
- Deep experience in aseptic processing, sterile fill‑finish, investigations, and cGMP quality systems; strong command of CDMO oversight.
- Experience with combination products (PFS/autoinjectors) and container‑closure systems is a plus.
- Excellent cross‑functional leadership and regulatory communication skills; track record contributing to CMC modules (IND/IMPD/BLA).
Why Join
- Shape and scale a Boston‑based biologics Drug Product capability with high visibility and impact.
- Work cross‑functionally to accelerate therapies from clinic to commercial.
- Collaborative culture focused on scientific rigor and operational excellence.
Boston, MA (Hybrid)
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