Senior Bioassay Scientist, CMC Potency & Automation

Cari; København; Hybrid; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk in Måløv seeks a Senior Research Scientist to lead potency assay development and optimization across clinical projects. You will translate project needs into robust analytical solutions, collaborating with technicians, scientists and project managers to deliver high-quality results.

The role emphasizes cGMP practices, regulatory involvement and continuous process improvement using LEAN and data-driven approaches.

Qualifications

• Hands-on experience designing and validating potency assays.
• Experience with cell-based bioassays and SPR methods in regulated settings.
• Knowledge of regulatory documentation and health authority interactions.
• Strong communication, collaboration and problem-solving abilities.

Responsibilities

• Design and prepare documentation for development and validation of potency assays (cell-based, enzymatic, chromogenic, SPR).
• Maintain and update analytical equipment documentation to ensure cGMP compliance.
• Collaborate with cross-organisational teams across CMC, Research, and manufacturing.
• Interact with health authorities and a wide range of internal/external stakeholders.

Skills

Bioassay development

SPR methods

cGMP regulation

Regulatory knowledge

Cross-functional collaboration

Communication skills

Initiative

LEAN principles

Automation and data

Education

Master's degree or PhD in pharmacy, chemistry, biophysics, engineering or related field

Job description

Novo Nordisk in Måløv seeks a Senior Research Scientist to lead potency assay development and optimization across clinical projects. You will translate project needs into robust analytical solutions, collaborating with technicians, scientists and project managers to deliver high-quality results.

The role emphasizes cGMP practices, regulatory involvement and continuous process improvement using LEAN and data-driven approaches.