Senior Analytical Project Lead: Drug Substance & Product

Novo Nordisk A/S

Gladsaxe Kommune

On-site

DKK 743,000 - 1,092,000

Full time

14 days+

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Job summary

Novo Nordisk A/S in Bagsværd, Denmark, is seeking a Senior Analytical Project Manager to lead analytical development across drug substances and products within the CMC Analytical Project Office. You will drive direction, align stakeholders, and ensure timely, high-quality deliveries on complex development programs.

The role requires experience in early- and late-phase development, knowledge of regulatory submissions, and collaboration with CMOs.

Qualifications

A relevant academic degree in Pharmacy, Chemistry, Biology, Engineering, or a related field.
Extensive experience in leading analytical activities in early- and/or late-phase clinical development.
Scientific expertise within analytical development for drug substance and/or drug product.
Experience working with one or more of: proteins/peptides, synthetic peptides or small molecules.
Regulatory submission experience and ideally experience with CMOs.
Proficiency in English at a professional level.

Responsibilities

Overseeing project management of analytical development, characterization activities and analytical strategies related to drug substance and drug product.
Guiding projects through different stages of clinical development in collaboration with internal stakeholders and CMOs.
Leading the analytical project team in developing regulatory documents and related materials.
Coordinating the transfer of analytical methods from R&D to CMC Development and manufacturing or to CMOs.