Senior CMC Project Lead, Early-Stage Biologics

Genmab A/S; København; On-site; DKK 645,000 - 967,000; Full time

Benefits offered by this job

Health insurance

Pension

Paid time off

Employee support programs

Job summary

Genmab A/S is seeking a Senior Operational CMC Project Manager to lead day-to-day CMC activities across Discovery to IND/CTA and early clinical development in Copenhagen. You will coordinate cross-functional teams, manage external CMOs/CDMOs, and drive integrated project plans to ensure timely, high-quality development programs.

You will collaborate with Process Development, Manufacturing, Regulatory, QA, and Supply Chain to translate CMC strategy into operational execution, while maintaining

Qualifications

• Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology or related field.
• Approximately 8–10 years of relevant experience in CMC/biologics development.
• Proven track record leading complex CMC development activities from early development through Phase I/II.
• Strong project management experience including planning, budgeting, risks and governance.
• Solid understanding of GMP manufacturing and CMC regulatory requirements.
• Experience working with external CMOs/CDMOs and regulatory CMC submissions.
• Excellent communication, collaboration, and problem-solving skills; fluent in English.

Responsibilities

• Drive operational execution of integrated CMC development plans from Discovery through IND/CTA and Phase I/II.
• Develop and maintain integrated CMC project plans with timelines, milestones, budgets and risks.
• Coordinate day-to-day CMC activities across multiple disciplines and with external partners.
• Manage interactions with CMOs/CDMOs, testing labs and vendors.
• Monitor progress, identify risks, mitigate issues and escalate when needed.
• Provide clear project status updates to teams and governance forums.
• Coordinate preparation of CMC documentation for regulatory submissions (INDs/CTAs).
• Follow up on quality activities, deviations, investigations and CAPAs affecting execution.
• Support project budgeting, forecasting and governance.
• Ensure compliance with Genmab Quality Management System and regulatory requirements.
• Identify opportunities for continuous improvement in processes and tools.

Skills

Project management

Cross-functional leadership

Biologics knowledge

CMOs/CDMOs coordination

Regulatory CMC submissions

English fluency

Education

Master's degree in Life Sciences/Pharmaceuticals

PhD or PM certification (advantage)

Job description

Genmab A/S is seeking a Senior Operational CMC Project Manager to lead day-to-day CMC activities across Discovery to IND/CTA and early clinical development in Copenhagen. You will coordinate cross-functional teams, manage external CMOs/CDMOs, and drive integrated project plans to ensure timely, high-quality development programs.

You will collaborate with Process Development, Manufacturing, Regulatory, QA, and Supply Chain to translate CMC strategy into operational execution, while maintaining