Senior Analytical Project Leader – Drug Development

Biopharma Careers

Gladsaxe Kommune

On-site

DKK 743,000 - 1,092,000

Full time

3 days ago
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Job summary

Novo Nordisk is seeking a Senior Analytical Project Manager to lead analytical development and strategy across complex drug development programs in a fast-paced environment.

You will join the CMC Analytical Project Office to drive alignment, manage cross-functional teams, and coordinate method transfers from research to production. The role requires leadership, strong communication, and deep knowledge of analytical development in drug substances and products.

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 proteins/peptides, synthetic peptides, or small molecules.
  • Regulatory submission experience and ideally experience in working with Contract Manufacturing Organisations (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 contract manufacturers.
  • Leading the analytical project team in a compelling and inspiring manner, including setting direction for the development of regulatory applications and various internal and external documents.
  • Coordinating the transfer of analytical methods from our research unit to CMC Development and subsequently to our manufacturing unit, Global Manufacturing & Supply, or to a contract manufacturer.

Skills

Project management
Cross-functional collaboration
Analytical development
Regulatory submissions
English proficiency
Drug development knowledge

Education

Pharmacy
Chemistry
Biology
Engineering
Related field

Job description

Novo Nordisk is seeking a Senior Analytical Project Manager to lead analytical development and strategy across complex drug development programs in a fast-paced environment.

You will join the CMC Analytical Project Office to drive alignment, manage cross-functional teams, and coordinate method transfers from research to production. The role requires leadership, strong communication, and deep knowledge of analytical development in drug substances and products.

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