Associate Director, Drug Product Development & Manufacturing
Listed on 2026-10-09
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Healthcare
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Pharmaceutical
Associate Director of Drug Product Development & Manufacturing, leading formulation, process development, and GMP manufacturing for clinical-stage biopharmaceuticals, primarily injectable nucleic acid-based therapies for neuromuscular and retinal diseases.
Responsibilities:oversee drug formulation, characterization, tech transfer, scale-up, and manufacturing activities at CDMOs; author and review technical documentation, batch records, and regulatory submissions; provide on-site oversight during manufacturing campaigns; collaborate across discovery, development, quality, clinical operations, and external vendors to ensure uninterrupted clinical supply.
Requirements:MS in a scientific discipline with 8+ years in biotech/pharma, with expertise in sterile drug formulation, aseptic fill-finish, and cGMP compliance; experience with parenteral biologics or nucleic acid therapies is preferred; strong communication and organizational skills; ability to travel (~20%).
High Value:sterile injectable drug manufacturing, nucleic acid-based therapeutics, clinical-stage assets, GMP compliance, CDMO oversight, cross-functional collaboration.
Work Setup:US remote, preference for candidates in New England with occasional travel to Boston headquarters.
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