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Meet Life Sciences
Senior Manager, Drug Product Development & Manufacturing
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Job Description
Senior Manager, Drug Product Development & Manufacturing at Meet Life Sciences Senior Manager, Drug Product Development & Manufacturing at Meet Life Sciences in Lincoln, Massachusetts Posted in about 22 hours ago.
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full-time Senior Manager, Drug Product Development & Manufacturing (Contract) I'm partnering with an innovative biotechnology company seeking a Senior Manager, Drug Product Development & Manufacturing to support biologics programs across commercial, clinical-stage, and early development products. This role will focus on drug product technology transfers, process development, and external manufacturing activities with U.S.-based CDMO partners. Requirements
- Bachelor's degree in a scientific discipline (Master's or PhD preferred)
- Strong experience in biologics drug product development and manufacturing
- Hands-on experience with sterile drug product manufacturing and aseptic processing
- Experience leading or supporting drug product technology transfers to CDMOs/CMOs
- Experience with process development and process characterization
- Experience supporting monoclonal antibody (mAb) products
- Experience supporting clinical and/or commercial manufacturing programs
- Ability to work independently in a fast-paced biotech environment Responsibilities
- Lead drug product technology transfer activities with external CDMOs
- Serve as a technical SME for drug product manufacturing and transfer activities
- Support sterile manufacturing, process development, and troubleshooting efforts
- Design and execute process characterization, in-use, and material compatibility studies
- Support commercial and clinical-stage biologic programs
- Collaborate cross-functionally with analytical, formulation, quality, manufacturing, and external partners
- Provide technical oversight for manufacturing activities and development programs
- Conduct occasional hands-on laboratory work to support development activities Preferred
- Experience with lyophilized biologic drug products
- Experience managing external CDMO relationships
- Experience supporting both clinical and commercial products
- Experience within a small or growing biotech company Due to the volume of applications, the fastest way to be considered is to call me directly at (919) 892-9841.