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Senior Manager, Drug Product Development and Manufacturing
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Based on Massachusetts data
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What they do
A Product Development Manager is responsible for developing new products by identifying potential markets or requirements, perhaps by conducting market research. Determines the product requirements, specifications, production timetables and pricing. introduction. May also develop marketing strategies.
$169,424 / year median in Massachusetts
-0% projected decline
Job Description
Senior Manager, Drug Product Development and Manufacturing at Meet Life Sciences Senior Manager, Drug Product Development and Manufacturing at Meet Life Sciences in Woburn, Massachusetts Posted in 10 days ago.
Type:
full-time Job Summary Seeking a Senior Manager to lead drug product development and technology transfer activities for late-phase and commercial sterile biologic products . This role will partner with cross-functional teams and external CMOs to support formulation and process development, technology transfer, and manufacturing strategy for liquid and lyophilized drug products. Responsibilities Lead technology transfers for sterile liquid and lyophilized biologics at CMOs. Design and oversee process development and characterization studies. Conduct developability and manufacturability assessments for early-phase candidates. Author and review protocols, reports, and CMC documentation. Manage CRO/CMO relationships and drive project milestones. Communicate project updates, risks, findings, and recommendations to stakeholders. Partner with Discovery and cross-functional teams to support candidate selection and drug product strategy. Qualifications PhD/MS with 5+ years or BS with 10+ years of experience in biologics formulation and drug product process development. Degree in pharmaceutical sciences, biochemistry, bioengineering, chemistry, or related field. Experience with monoclonal antibodies or other biologic drug products, including sterile liquid and/or lyophilized formulations. Proven experience managing CMOs for technology transfer, process development, and sterile fill/finish manufacturing. Willingness to travel up to 10%.