Senior Bioassay Scientist, CMC Potency Development

Novo Nordisk A/S; Måløv; Remote; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Måløv is seeking a Senior Research Scientist to lead the development and optimization of potency bioassays across clinical programs. You’ll translate project needs into robust analytical solutions and work with lab technicians, scientists and project managers.

The role emphasizes regulatory documentation, cGMP, cross‑functional collaboration, and the use of LEAN principles, automation and data to improve assay development and execution.

Qualifications

• Hands-on experience developing cell-based bioassays or SPR methods, preferably in a cGMP-regulated environment.
• Knowledge of regulatory documentation and experience supporting interactions with health authorities.
• Strong communication and collaboration skills, with initiative and a can-do attitude.

Responsibilities

• Design and prepare documentation for development and validation of potency assays from phase 1 to 3.
• Maintain and update analytical equipment documentation to ensure sufficient cGMP.
• Collaborate in cross-organisational project groups across CMC, Research Units and manufacturing.
• Interact with Health Authorities and a wide range of internal and external stakeholders.

Skills

Hands-on bioassays/SPR

Regulatory documentation

Communication & collaboration

Education

Master’s or PhD in pharmacy/chemistry/biophysics/engineering

Job description

Novo Nordisk A/S in Måløv is seeking a Senior Research Scientist to lead the development and optimization of potency bioassays across clinical programs. You’ll translate project needs into robust analytical solutions and work with lab technicians, scientists and project managers.

The role emphasizes regulatory documentation, cGMP, cross‑functional collaboration, and the use of LEAN principles, automation and data to improve assay development and execution.