Senior Analytical PM, CMC Drug Substance & Product

Novo Nordisk A/S; Gladsaxe Kommune; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk A/S in Bagsværd, Denmark, seeks a Senior Analytical Project Manager in the CMC Analytical Project Office to lead analytical development programs for drug substances and products across stages.

You will drive cross-functional collaboration with analytical departments, Research, Global Manufacturing & Supply, Quality Assurance and Regulatory Affairs, oversee development strategies, and coordinate method transfers to CMOs and manufacturing units.

Qualifications

• Academic degree in Pharmacy, Chemistry, Biology, Engineering, or related field.
• Extensive experience leading analytical activities in early- and/or late-phase development.
• Scientific expertise in analytical development for drug substance and/or drug product.
• Experience with proteins/peptides, synthetic peptides, or small molecules.
• Regulatory submission experience and CMOs collaboration preferred.
• Professional English proficiency and collaboration skills.

Responsibilities

• Overseeing analytical development, characterization activities and strategies for substance and product.
• Guiding projects through clinical development stages with internal and external partners.
• Leading the analytical project team and regulatory documentation development.
• Coordinating transfer of analytical methods to CMOs, R&D and manufacturing units.

Skills

Pharmacy degree

Chemistry background

Biology background

Engineering background

Analytical development leadership

English proficiency

Education

Pharmacy degree

Chemistry degree

Biology degree

Engineering degree

Job description

Novo Nordisk A/S in Bagsværd, Denmark, seeks a Senior Analytical Project Manager in the CMC Analytical Project Office to lead analytical development programs for drug substances and products across stages.

You will drive cross-functional collaboration with analytical departments, Research, Global Manufacturing & Supply, Quality Assurance and Regulatory Affairs, oversee development strategies, and coordinate method transfers to CMOs and manufacturing units.