Senior Downstream Scientist: Peptide Purification & Scale-Up

Novo Nordisk A/S; Høje-Taastrup Kommune; Presencial; DKK 750 000 - 950 000; Tempo integral

Resumo da oferta

Novo Nordisk is seeking a Senior Downstream Scientist to guide peptide-based process transfer from development to large-scale manufacturing. You will oversee downstream purification, drying, and batch execution, ensuring GMP-compliant documentation and regulatory submissions progress smoothly.

The role spans cross-functional teams across MSAT and API Manufacturing, with partnerships from development to production, including CMOs. Travel about 20% is expected.

Qualificações

• A MsC or PhD in chemical or biochemical sciences, chemical engineering or an equivalent field.
• Extensive experience with downstream purification of peptide- or protein-based therapeutics in commercial and/or late-phase drug substance manufacturing.
• Experience with scale-up and process transfer to large-scale manufacturing.
• Solid GMP experience from cGMP-regulated manufacturing areas, preferably for commercial processes, and a clear understanding of GMP requirements for drug substance manufacturing.
• Good technical and practical knowledge of equipment and automation, and a practical understanding of at-scale unit operations for chromatographic separation and filtration.
• A practical, solution-oriented approach that turns theory into workable answers to technical challenges.
• Clear communication and collaboration with internal and external stakeholders across development and production – working well in a team and independently on complex tasks to keep progress on time.
• Readiness to travel approximately 20% of the time.

Responsabilidades

• Provide scientific and technical stewardship during process transfer, process development and batch execution at CMOs.
• Lead characterization work for downstream purification and drying steps on-site at CMOs.
• Own assigned deliverables in cross-organisational groups for transfer, batch execution and process validation.
• Troubleshoot process execution at CMOs, assess changes and deviations, and participate in problem solving.
• Act as process and product expert in cross-functional projects, finalising scientific and technical documentation on time.
• Author, co-author and review regulatory registration documents.

Conhecimentos

Downstream purification

Process transfer

Scale-up

GMP experience

Chromatography

Filtration

Problem-solving

Communication

Travel readiness

Formação académica

MsC or PhD in chemical/biochemical sciences or chemical engineering

Ferramentas

Automation systems

Equipment understanding

Descrição da oferta de emprego

Novo Nordisk is seeking a Senior Downstream Scientist to guide peptide-based process transfer from development to large-scale manufacturing. You will oversee downstream purification, drying, and batch execution, ensuring GMP-compliant documentation and regulatory submissions progress smoothly.

The role spans cross-functional teams across MSAT and API Manufacturing, with partnerships from development to production, including CMOs. Travel about 20% is expected.