Senior Manager, Drug Product Development & Manufacturing at Meet Life Sciences Senior Manager, Drug Product Development & Manufacturing at Meet Life Sciences in Lexington, Massachusetts Posted in about 22 hours ago.

Type:

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.