Analytical Project Lead - API Analytics & CMOs

Novo Nordisk; Taastrup; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk is seeking an Analytical Project Manager to lead analytical activities for chemically synthesized APIs across CMOs and internal teams. The role spans from post phase 3 to commercialization, combining project management with SME responsibilities.

Based in Høje Taastrup, Denmark, the position requires GMP/ICH compliance experience, method validation, and strong communication to coordinate with global partners and governance boards.

Qualifications

• Degree in Pharmacy or related scientific discipline (B.Sc./M.Sc./PhD).
• Minimum 5 years of experience in a similar pharmaceutical role.
• Experience with late-phase (phase 3) development projects.
• Experience with GMP, ICH guidelines and regulatory requirements.
• Experience with method validation.
• English proficiency at a professional level.
• Strong leadership and communication skills.

Responsibilities

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

Skills

Leadership

Communication

English proficiency

Education

Degree in Pharmacy or related scientific discipline (B.Sc./M.Sc./PhD)

Job description

Novo Nordisk is seeking an Analytical Project Manager to lead analytical activities for chemically synthesized APIs across CMOs and internal teams. The role spans from post phase 3 to commercialization, combining project management with SME responsibilities.

Based in Høje Taastrup, Denmark, the position requires GMP/ICH compliance experience, method validation, and strong communication to coordinate with global partners and governance boards.