Associate Director, Biologics CMC Drug Product

📋 Description

• Develop biologics drug product formulations, processes, and delivery methods across lifecycle.
• Manage tech transfer of drug product processes to CMOs and oversee manufacturing.
• Develop external drug product development/manufacturing capabilities and network.
• Ensure compliance with FDA, cGMP and ICH guidelines.
• Author and review technical documents and regulatory filings; support agency interactions and inspections.
• Support development and implementation of new process technologies; stay current on trends.

🎯 Requirements

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, or related field.
• 8+ years in biotech/pharma drug product development/manufacturing.
• Hands-on knowledge of protein formulation development, fill–finish, and non‑mAb formats.
• Proven ability to manage global external vendors for development, manufacturing, and testing.
• Experience generating CMC sections for IND/IMPD/BLA/MAA filings.
• Familiar with phase-appropriate cGMP; FDA/EU/ICH guidelines.
• Experience in cross-functional, matrixed environments; collaboration and results-driven.
• Excellent decision-making and written/verbal communication skills; self-starter.

🎁 Benefits

• Annual bonus (20% of salary).
• Annual equity awards.
• Medical, dental, vision insurance; life and disability coverage.
• 401(k) plan with employer match.
• Paid time off, holidays, and parental leave.
• Tuition reimbursement.