Director, Drug Product Development, Biologics
$220,000–$260,000 year
Hybrid · Palo Alto, California, United States
Job Summary
Director, Drug Product Development to manage formulation, process, and delivery-device development for protein therapeutics across the clinical pipeline. Responsibilities include formulating and optimizing drug product manufacturing processes (fill-finish, scale-up, technology transfer), development of delivery devices (prefilled syringes, autoinjectors), overseeing external labs and CDMOs, ensuring cGMP compliance, and coordinating with QA, Regulatory, and cross-functional teams to support regulatory filings and manufacturing readiness.
Required Qualifications
- Degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related field
- 8+ years of relevant industry experience with PhD, 10+ years with MS, or 12+ years with BS in biologics drug product development, formulation, process development, or CMC technical operations
- Demonstrated experience in formulation development and drug product process development
- Experience with parenteral biologic drug products, including liquid and/or lyophilized formulations
- Experience with fill-finish process development, technology transfer, GMP manufacturing, and CDMO oversight
- Demonstrated experience in development and implementation delivery devices (PFS, autoinjectors, etc.)
- Demonstrated strong knowledge of FDA and ICH CMC requirements for biologics
- Experience with monoclonal antibodies and fusion proteins
- Strong technical judgment and ability to make phase-appropriate recommendations in a lean biotech environment
- Coordination and oversight of external vendors, CDMOs, and manufacturing activities
- Regulatory documentation review and collaboration for CMC amendments and filings
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