Associate Director, Drug Product CMC
Greater Philadelphia Area
Hybrid
Job Summary:
The Associate Director of Drug Product CMC leads and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Associate Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones.
Key Responsibilities:
- Provide guidance on CMC aspects of drug development programs, from preclinical through commercial stages, to ensure alignment with business objectives.
- Oversee technology transfer activities to GMP manufacturing sites and ensure smooth transition from development to production.
- Drive the preparation and submission of CMC sections for regulatory filings, including INDs, NDAs, BLAs, and MAAs, working closely with regulatory affairs teams.
- Collaborate with internal teams, including R&D, quality assurance, clinical, and supply chain, as well as external vendors and contract manufacturing organizations (CMOs).
- Working knowledge of drug product formulation, fill/finish development and PIP for sterile dosages
- Work closely with Contract Development and Manufacturing Organizations (CDMOs) to design processes needed to perform aseptic filling operations in a GMP environment
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 8+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.).
- In-depth experience with drug product development, formulation, process development, and manufacturing.
- Proven track record in CMC regulatory submissions (IND, NDA/BLA)
- Proven expertise in formulation & drug product development (liquid and lyophilized), GMP manufacturing of drug products
- Experienced with both small and biologic drug products.
- Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE.
- Prior experience working with external manufacturing partners and contract organizations.
What We Offer:
- Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies.
- Collaborative work environment with professional development and career growth opportunities.
- Competitive compensation package, including comprehensive benefits and stock options.
