Senior Analytical Project Lead, Drug Development (CMC)

Novo Nordisk A/S; Denmark; Remote; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk A/S in Bagsværd invites a Senior Analytical Project Manager to lead analytical development strategies within the CMC Analytical Project Office. You will drive cross-functional collaboration across technology platforms, molecule types and project phases to deliver timely, high-quality results for drug substance and drug product.

You will oversee project management, guide projects through clinical development stages with internal teams and CMOs, and lead regulatory documentation for

Qualifications

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

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 developing 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

Advanced degree

Analytical leadership

Analytical development

Proteins/peptides or small molecules

Regulatory submissions

English proficiency

Education

Science/engineering/related degree

Job description

Novo Nordisk A/S in Bagsværd invites a Senior Analytical Project Manager to lead analytical development strategies within the CMC Analytical Project Office. You will drive cross-functional collaboration across technology platforms, molecule types and project phases to deliver timely, high-quality results for drug substance and drug product.

You will oversee project management, guide projects through clinical development stages with internal teams and CMOs, and lead regulatory documentation for