Lead Analytical Project Manager, Synthetic API

Novo Nordisk A/S; Denmark; Remote; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Denmark is seeking an Analytical Project Manager to lead analytical activities for chemically synthesized APIs across CMOs and internal teams. You will serve as project manager and SME, guiding post-phase 3 activities toward commercialization.

Responsibilities include coordinating analytical work, preparing regulatory submissions, ensuring method robustness, and defining strategy for market launch. Travel is expected occasionally within a global collaboration.

Qualifications

• Minimum 5 years of experience in a similar pharmaceutical project/analytical role.
• Experience with late-phase (Phase 3) pharmaceutical development projects.
• GMP, ICH guidelines and regulatory requirements knowledge.
• English proficiency and strong communication with stakeholders.

Responsibilities

• Coordinate analytical activities at CMOs and internally.
• Lead preparation and coordination of regulatory submissions for development projects (e.g., NDAs/MAAs/DMFs).
• Ensure analytical methods are compliant and robust for market use in collaboration with CMOs.
• Define and lead the analytical strategy towards market launch.
• Represent the analytical drug substance area in governance boards.
• Review and approve CMO-related documents (validation protocols/reports, analytical procedures).
• Provide SME on method lifecycle management and analytical troubleshooting.

Skills

Project management

Leadership

Regulatory knowledge

Analytical chemistry

Communication

Education

Bachelor/Master/PhD in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related field

Job description

Novo Nordisk A/S in Denmark is seeking an Analytical Project Manager to lead analytical activities for chemically synthesized APIs across CMOs and internal teams. You will serve as project manager and SME, guiding post-phase 3 activities toward commercialization.

Responsibilities include coordinating analytical work, preparing regulatory submissions, ensuring method robustness, and defining strategy for market launch. Travel is expected occasionally within a global collaboration.