Senior Drug Substance Scientist

Zealand Pharma; Gladsaxe Kommune; Remote; DKK 900.000 - 1.100.000; Vollzeit

Zusammenfassung

Zealand Pharma in Denmark is seeking a Senior Drug Substance Scientist to lead late-stage drug substance development with CDMO partners and drive CMC strategy.

You will be a pivotal expert, shaping regulatory submissions, coordinating with CDMOs, and contributing to risk assessments and documentation while maintaining ownership of your area.

Qualifikationen

• 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 SPPS and related processes for synthetic peptides.
• Experience with drug substance outsourcing and CDMO collaboration.
• Knowledge of Quality Risk Management (FMEA), GMP, and regulatory requirements in late-stage CMC.

Aufgaben

• 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.
• Join a highly experienced team of experts within CMC Development and contribute to ambitious results.

Kenntnisse

Late-stage development

CDMO collaboration

CMC development

SPPS

FMEA & GMP

Regulatory submissions

Ownership mindset

Ausbildung

MSc/PhD in chemistry/biochemistry/pharmaceutical sciences

Jobbeschreibung

## Senior Drug Substance ScientistApply: Sydmarken 11: Full time: Posted 2 Days Ago: JR395Does 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. Interested in bonding with us? Then please apply no later than **October 25, 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 **Director**, **Iben Meier** and **[e-mail]**.