Head of Drug Substance & Analytical Development

## Head of Drug Substance & Analytical Development Apply locations:
Cambridge time type:
Full time posted on:
Posted 3 Days Agojob requisition :
JR326

Does it excite you to build something from the ground up, and do you have deep expertise in peptide process chemistry and leading high-performing teams? If this sounds like you, and you are ready to shape the future of peptide drug substance development at a fast-growing biotech, then you could be our new colleague.
** Your new position
** 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 Phase 1 and 2, laying the foundation for Phase 3-ready processes, and is central to enabling Zealand's growing pipeline of peptide therapeutics to reach patients.
* We offer exciting 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 Phase 2
* 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 Phase 3
* Partner closely with Analytical Development and Manufacturing to ensure processes are scalable, robust, and sustainable
* Drive technology transfer in collab with DK drug substance team to external CMOs, ensuring seamless transition from development to production
** Your profile
** The ideal candidate brings a track record of scientific excellence in peptide process chemistry combined with the leadership presence to inspire and grow a team. A pragmatic problem-solver and strategic thinker, this person thrives in a dynamic, build-phase environment and can balance hands-on technical depth with cross-functional influence. Comfort with ambiguity and a bias for action are essential.
* Advanced degree (PhD preferred) in Chemistry, Chemical Engineering, or a related field, with 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 Phase 1, 2 and 3 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 Phase 2, with an eye toward building a robust foundation for Phase 3 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,…