Senior Drug Substance Scientist

Zealand Pharma A/S; Gladsaxe Kommune; On-site; DKK 900,000 - 1,300,000; Full time

Job summary

Zealand Pharma A/S is seeking a Senior Drug Substance Scientist to lead late-stage drug substance development and coordinate CDMO partnerships. The role emphasizes technical transfer, risk assessment, and documentation across development projects.

You will shape CMC strategy and drive regulatory interactions with internal teams and external partners. You will join a seasoned CMC Development group, contributing to submissions and ensuring robust processes, quality, and compliance in late-stage

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 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

• 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.

Skills

Late-stage development

CDMO collaboration

GMP knowledge

Regulatory knowledge

SPPS knowledge

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.

Join us and let's bond and be bold.

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

About Zealand Pharma

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.

Since our founding in 1998, Zealand Pharma has built a core expertise in the discovery, design, and development of therapeutic peptides. This expertise has led to an R&D pipeline of innovative investigational candidates designed to address a broad range of disease areas. We have four therapeutic focus areas: obesity, rare diseases, chronic inflammation, and type 1 diabetes. In obesity, our peptide capabilities place us in a unique position to address a vast global health challenge and positively impact hundreds of millions of lives. Within rare diseases, we have a long-standing commitment to deliver new treatments to patients living with congenital hyperinsulinism and short bowel syndrome. For chronic inflammatory diseases, we are progressing peptide programs focused on high-profile targets shown to be difficult to address with small molecules and antibodies. For type 1 diabetes, we aspire to change the management of this disease. Our strategy is to pursue global co-development and commercialization partnerships that complement and extend our capabilities across the value chain to deliver new peptide therapies to people who need them.