Associate Director, Drug Product
About this role
About the Role
Associate Director, Drug Product at Disc Medicine, a clinical-stage biopharmaceutical company focused on hematologic diseases, hybrid role based in Massachusetts with remote flexibility. This role supports drug product development programs, guiding development through early clinical supply and coordinating with R&D, manufacturing, and regulatory teams.
What You'll Do
- Lead drug product development and CMC activities for Disc Medicine's product portfolio, including development plans, risk assessments, and regulatory strategy.
- Manage tech transfer and scale-up of drug product processes to CMOs and manufacturing sites, ensuring quality, timelines, and budget.
- Collaborate with Formulation, Process Development, Analytics, Regulatory, QA, and Manufacturing to advance programs and prepare regulatory filings (IND/CMC sections).
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