Head of Drug Substance & Analytical Development

Zealand Pharma • Cambridge, MA

1d • Onsite

About The Position

This role is for a Global Head of Drug Substance – Senior Director, based in Boston. It offers a unique opportunity to establish and lead a Peptide Process Development function from the beginning. The position involves building a Boston-based lab and team, while also providing global leadership for Drug Substance. The role covers the entire process from synthetic route scouting through Phase 1 and 2, preparing for Phase 3-ready processes, and is crucial for advancing Zealand's pipeline of peptide therapeutics. The position is responsible for establishing and leading the Peptide Process Development lab in Boston, including hiring and developing a local team, and providing global leadership and strategic direction for the Drug Substance function from early discovery to Phase 2. Key responsibilities include leading synthetic route scouting and salt selection, evaluating alternative processes based on yield, COGS, manufacturability, and scalability. The role also involves developing and optimizing upstream and downstream process design for scalable, cost-effective synthetic routes suitable for initial clinical trials and as a foundation for Phase 3. Collaboration with Analytical Development and Manufacturing is essential to ensure processes are scalable, robust, and sustainable. Additionally, the role drives technology transfer in collaboration with the DK drug substance team to external CMOs, ensuring a smooth transition from development to production.

Requirements

• Track record of scientific excellence in peptide process chemistry
• Leadership presence to inspire and grow a team
• Pragmatic problem-solver and strategic thinker
• Ability to thrive in a dynamic, build-phase environment
• Ability to balance hands-on technical depth with cross-functional influence
• Comfort with ambiguity and a bias for action
• 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 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

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 collaboration with DK drug substance team to external CMOs, ensuring seamless transition from development to production

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree