Lifecycle CMC Project Manager - Global Manufacturing

Genmab

København

On-site

DKK 597,000 - 896,000

Full time

19 hours ago
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Benefits offered by this job

Pension
Health insurance and wellness benefits
Paid time off
Employee support programs

Job summary

Genmab is seeking a Project Manager CMC Product Lifecycle Management to join the CMC Life Cycle Management (LCM) Team. You will manage lifecycle activities, manufacturing oversight, and regulatory compliance across commercial products globally.

You will collaborate with Commercial Supply Chain, MSAT, Regulatory CMC and External Manufacturing to ensure successful post‑approval activities and lifecycle execution in a cross‑functional, global environment.

Qualifications

  • Master's degree in science or related technical discipline.
  • 4+ years in biopharmaceutical industry, preferably manufacturing operations or lifecycle.
  • Proven track record in CMC project management or manufacturing operations across development and commercialization.
  • Experience managing cross-functional teams in regulated environments.
  • Prior experience with CMOs and global cGMP knowledge.

Responsibilities

  • Provide manufacturing oversight and lifecycle activities for an assigned track post‑launch.
  • Lead operational governance with internal functions and CMOs, aligning priorities and tracking actions.
  • Collaborate with internal and external stakeholders to ensure quality, regulatory compliance and supply continuity.
  • Coordinate issue resolution, risk management, and escalation with proposed next steps.
  • Drive manufacturing changes, projects and improvements within scope, timelines and budgets.
  • Support submission documentation coordination across stakeholders and CMOs/partners and optimize yield and cost of goods.

Skills

CMC project management
Manufacturing operations
Regulatory CMC
Cross-functional collaboration
Stakeholder management
English proficiency
Multicultural teamwork
Project governance

Education

Master's degree in science or related discipline

Job description

Genmab is seeking a Project Manager CMC Product Lifecycle Management to join the CMC Life Cycle Management (LCM) Team. You will manage lifecycle activities, manufacturing oversight, and regulatory compliance across commercial products globally.

You will collaborate with Commercial Supply Chain, MSAT, Regulatory CMC and External Manufacturing to ensure successful post‑approval activities and lifecycle execution in a cross‑functional, global environment.

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