Meet Life Sciences
Senior Manager Drug Product Biologics
Meet Life Sciences, San Diego, California, United States, 92189
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Candidates need to work a hybrid model in San Diego, CA - 3 days in office.
Overview
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Science Industries
Staffing and Recruiting Biotechnology Research Pharmaceutical Manufacturing
#J-18808-Ljbffr
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 Seniority level
Mid-Senior level Employment type
Full-time Job function
Science Industries
Staffing and Recruiting Biotechnology Research Pharmaceutical Manufacturing
#J-18808-Ljbffr