Senior Drug Substance Scientist

Zealand Pharma; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Zealand Pharma is seeking a Senior Drug Substance Scientist to lead late-stage drug substance development and manage CDMO collaborations. You will drive strategy, oversee technical transfer, and support regulatory interactions, with ownership of your area and an emphasis on high-quality documentation and risk management.

You will work within a seasoned CMC Development team, contributing to submissions and ensuring smooth cross-functional progress toward regulatory approval.

Qualifications

• MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field.
• Solid experience in the pharmaceutical industry.
• Experience in late-stage process development, scale-up, and preferably process validation (PPQ).
• Experience in working with Solid-Phase Peptide Synthesis (SPPS) and related processes for synthetic peptides is an advantage
• Experience with drug substance outsourcing and CDMO collaboration
• Knowledge of Quality Risk Management (FMEA), GMP, and regulatory requirements in late-stage CMC

Responsibilities

• Late-stage drug substance development across a broad range of activities in development projects.
• Coordinate DS CDMO partners with oversight, communication and knowledge transfer.
• Support development and technical manufacturing activities at CDMOs, including documentation and risk assessments.
• Contribute to submissions and regulatory interactions with Regulatory Affairs and CDMOs.
• Provide scientific and strategic input to regulatory submissions and interactions.

Education

MSc/PhD in chemistry/biochemistry/pharmaceutical sciences

Job description

Does it excite you to work with late-stage drug substance development and CDMO collaboration, and do you have experience with CMC development for synthetic peptides? 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 our new Senior Drug Substance Scientist your responsibilities will include late-stage drug substance development across a broad range of activities in development projects, with effective coordination of our Contract Development and Manufacturing Organization (CDMO) partners as a significant part of the role. You will act as a professional anchor and expert in your field, playing a key role in driving late-stage drug substance strategy. You’ll be empowered to shape both the direction of the role and how you execute it day to day, with real ownership of your area.

We offer exciting responsibilities:

• Drug substance late-stage development, technical transfer and upscale in development projects

• Managing the collaboration with DS CDMOs, including oversight plans, day-to-day communication, and knowledge transfer

• Supporting development and technical manufacturing activities at CDMOs, including documentation, risk assessments and reports

• Active contribution to the CMC team, working collaboratively on project progress toward regulatory approval — within Zealand Pharma and with external partners

• Driving scientific and strategic input to submissions and regulatory interactions, in collaboration with Regulatory Affairs, partners and CDMOs

Your profile

You’re energized by collaborative, fun teamwork, excel at handling complex tasks, and enjoy continuous learning. You bring an independent mindset, are ready to take ownership of your area, and are proactive and adaptable when facing new challenges.

• M.Sc./PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field

• Solid experience in the pharmaceutical industry

• Experience in late-stage process development, scale-up, and preferably process validation (PPQ)

• Experience in working with Solid-Phase Peptide Synthesis (SPPS) and related processes for synthetic peptides is an advantage

• Experience with drug substance outsourcing and CDMO collaboration

• Knowledge of Quality Risk Management (FMEA), GMP, and regulatory requirements in late-stage CMC

Your new team

You will join a highly experienced team of experts within CMC Development, where we value a friendly, helpful, fun atmosphere and work together to achieve ambitious results.

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.

Apply by October 25, 2026.

For further information, please contact Director , Iben Meier and [e-mail].

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 advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

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