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Global Head of Drug Substance

Zealand Pharma U.S., Inc.

Your new position at Zealand Pharma is looking for a Global Head of Drug Substance – Senior Director, based in Boston. This is a rare opportunity to establish and lead a Peptide Process Development function from the ground up, building a Boston–based lab and team while providing global leadership across Drug Substance. The role owns the full arc from synthetic route scouting through Phase1 and2, laying the foundation for Phase3‑ready processes, and is central to enabling Zealand's growing pipeline of peptide therapeutics to reach patients. Responsibilities Establish and lead the Peptide Process Development lab in Boston, including hiring and developing a high‑performing local team. Provide global leadership and strategic direction for the Drug Substance function from early discovery to Phase2. Lead synthetic route scouting and salt selection, evaluating alternative processes with yield, COGS, manufacturability, and scalability as key decision criteria. Develop and optimize upstream and downstream process design to establish scalable, cost‑effective synthetic routes fit for initial clinical trials and as the foundation for Phase3. Partner closely with Analytical Development and Manufacturing to ensure processes are scalable, robust, and sustainable. Drive technology transfer in collaboration with the DK drug substance team to external CMOs, ensuring a seamless transition from development to production. Lead a globally distributed Drug Substance organization spanning two sites. Qualifications Advanced degree (PhD preferred) in Chemistry, Chemical Engineering, or a related field. Extensive experience in peptide process development. Demonstrated leadership experience managing and developing cross‑functional or global technical teams. Deep expertise in solid‑phase and/or liquid‑phase peptide synthesis, purification, and process optimization across Phase1,2 and3 clinical stages. Broad experience across the full process development cycle, including synthetic route scouting, salt selection, upstream and downstream process optimization, and evaluation of process alternatives with a focus on yield, COGS, manufacturability, and scalability. Knowledge of process development and technology transfer to GMP manufacturing, including CMO management. Experience defining manufacturing strategies from early discovery to Phase2, with an eye toward building a robust foundation for Phase3 and commercial. Strong cross‑functional collaboration skills, particularly with Analytical Development and Manufacturing. Your New Team This role leads a globally distributed Drug Substance organization spanning two sites. In Boston, the role will establish a process wet lab staffed with process scientists focused on hands‑on peptide process development and optimization. In Copenhagen, a DS team serves as the primary connection point to CMOs, ensuring alignment on manufacturing strategies, technology transfer, and day‑to‑day CMO oversight. Together, the two teams form a cohesive global function with complementary responsibilities, working in close partnership with colleagues across Research, Analytical Development, and Manufacturing. We are committed to an inclusive recruitment process and welcome applications from all job applicants. #J-18808-Ljbffr Zealand Pharma U.S., Inc.

Vacancy posted 5 days ago
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