Sr Manager Drug Product

Sr Manager Drug Product

*Candidates need to work a hybrid model in San Diego, CA*

Meet has partnered with a clinical-stage biopharmaceutical company that leads the development, manufacturing, and lifecycle strategies of biologic drug products, ensuring production quality, regulatory compliance, and clinical supply. Collaborates cross-functionally to manage technology transfers and formulation development, while providing strategic guidance to internal teams and external partners.

Key Responsibilities

• Lead drug substance and product manufacturing at CMOs, including validation, PPQ, stability, and GMP runs.
• Provide scientific and technical leadership across development, clinical supply, and commercialization stages.
• Drive technology transfer, scale-up, and final product assembly at CDMOs, managing documentation and execution.
• Collaborate with QA and Regulatory Affairs to ensure compliance, manage complaints, and support risk mitigation.
• Oversee CRO/CMO coordination, review data and reports, author regulatory documents, and assist with budgeting.

Key Qualifications

• 7+ years working in pharma/biotech, focused on biologics and combination products like autoinjectors and prefilled syringes.
• Strong skills in formulation, process development, and scaling up drug products.
• Experienced with analytical tools (like HPLC) and writing regulatory documents (IND, BLA).
• Knows global regulations (FDA, EMA, ICH) and works well in fast-paced teams.
• Motivated, independent, and great at managing multiple projects and presenting to senior leaders.

Please reach out to Martin Wenzel if you're interested in learning more: martin.wenzel@meetlifesciences.com