CMC Integration Specialist

4 days ago


Copenhagen, Copenhagen, Denmark Genmab AS Full time
About the Role

We are seeking a highly skilled and experienced Senior Technical Operations Manager to join our CMC Integration Team in New Product Introduction (NPI) CMC at Genmab A/S. The successful candidate will be responsible for developing and supporting required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.

Key Responsibilities
  • Integration of new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
  • Managing specific analytical/process activities at Contract Manufacturing Organizations (CMOs) related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
  • Supporting the CMC Project Management team to solve project-specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites.
  • Supporting and reviewing regulatory CMC submissions (IND/CTA).
  • SUPPORTING AND FOLLOWING UP ON CMO AND INTERNAL QUALITY EVENTS SUCH AS CHANGES OR DEVIATIONS.
About You
  • You bring a broad background from CMC development within Bioprocess Technology/Bioprocess Analytics.
  • You have experience working in a fast-growing, dynamic company or a strong desire to.
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have basic knowledge of Project Management tools.
About Genmab A/S

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.

Benefits
  • The estimated annual salary for this position is around $120,000 - $180,000 depending on experience.
  • Genmab A/S offers a comprehensive benefits package including health insurance, retirement savings plan, and paid time off.

This role offers a unique opportunity to work with a leading biotechnology company, develop your skills and expertise, and contribute to the development of innovative cancer treatments.



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