Senior Drug Substance Scientist: Late-Stage CMC & CDMO Strategy

Zealand Pharma; Denmark; Presencial; DKK 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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.

Educación

MSc/PhD in chemistry/biochemistry/pharmaceutical sciences

Descripción del empleo

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.