Senior Drug Substance Specialist

Does it excite you to work with late-stage peptide drug substance manufacturing, process validation (Process Performance Qualification; PPQ) and CDMO oversight?, and do you have experience with GMP manufacturing execution and technical transfer? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague.

Your new position
As Senior Drug Substance Specialist, the role will be a key expert and professional anchor for late-stage drug substance manufacturing of peptide-based medicines. The position covers scale-up, process validation (PPQ) and manufacturing execution, with support into the commercial phase. Close collaboration and coordination with Contract Development and Manufacturing Organizations (CDMOs) is central to success. The role offers strong influence on manufacturing strategy, standards, and daily decision-making across Chemistry, Manufacturing and Controls (CMC) Development and Life Cycle Management projects.

We offer exciting responsibilities:

• Lead late-stage drug substance manufacturing activities, including scale-up and PPQ for synthetic peptides
• Act as key point of contact for drug substance CDMOs and coordinate day-to-day collaboration, oversight-plan execution, and technical knowledge transfer
• Provide on-site support at CDMO sites as needed to support GMP execution, troubleshooting, and alignment on agreed standards
• Review and approve relevant manufacturing documentation (e.g., batch records) and support assessment of deviations, investigations, and change controls
• Contribute manufacturing input to CMC planning and execution to support regulatory submissions, approvals, and commercial readiness
• Drive continuous improvement initiatives across external manufacturing operations and internal processes, workflows, and standards

Your profile
The ideal candidate thrives in collaborative, engaging teamwork and enjoys handling complex tasks with strong execution. The role calls for an independent mindset, sound judgement, and a proactive, structured approach to problem-solving. Strong stakeholder management and communication skills are essential to create alignment internally and with external manufacturing partners.

• MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related field
• 7+ years of experience in the pharmaceutical/biotech industry with direct involvement in drug substance manufacturing operations
• Proven experience with peptide process scale-up and execution of PPQ in a GMP setting
• Demonstrated experience outsourcing drug substance production and working effectively with CDMO manufacturing teams
• Must-have: hands-on experience with Quality Risk Management, including tools such as FMEA (Failure Modes and Effects Analysis)
• Solid knowledge of late-stage drug substance development requirements, including GMP expectations and relevant regulatory standards

Your new team
You will join a newly formed team in Drug Substance Manufacturing within the CMC area and work closely with a broad range of experts across CMC disciplines. The team culture is characterized by cross-functional collaboration, strong engagement, and a friendly, execution-focused atmosphere. The role contributes to establishing robust ways of working and delivering late-stage milestones together with internal stakeholders and external partners.

Let's bond and be bold
We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture.

Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let's bond and be bold.

Interested in bonding with us? Then please apply no later than March 2, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying.

For further information, please contact Head of Manufacturing, Rasmus Sandberg-Schaal and [email protected] / +45 3111 6287.

We are committed to an inclusive recruitment process and welcome applications from all job applicants.

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a team in the U.S. For more information about Zealand Pharma's business and activities, please visit www.zealandpharma.com.