Drug Product, Dir.

📋 Description

• Drug product development lead within the CMC department for small molecule programs.
• Oversee formulation development, process optimization, tech transfer, and external CDMO
• Ensure data packages support regulatory filings and quality controls with QA/Regulatory.
• Lead tech transfer from development to manufacturing for scalable, robust processes.
• Direct formulation development with QbD principles and CPPs/CQAs characterization.
• Collaborate with cross-functional teams to drive regulatory readiness and IND/NDA submissions.

🎯 Requirements

• Lead drug product development activities for late-stage programs in CMC.
• Experience with regulatory filings, CDMOs, and manufacturing transfer.
• Strong knowledge of QbD, CPPs, PARs, CQAs, and stability programs.
• Ability to manage internal/external teams and drive CAPAs with QA.
• Author/review regulatory documents for IND/NDA submissions.
• Collaborative, results-driven leader with cross-functional influence.

🎁 Benefits

• Competitive compensation aligning with role and experience.
• Equity opportunities and comprehensive benefits.