Chief Technical Integration Director
2 months ago
At Genmab, we are dedicated to transforming the lives of patients through innovative cancer treatment.
About the Role
We are seeking a skilled Clinical Manufacturing and Control (CMC) Technical Integration Director to join our team in Copenhagen. As a CMC Technical Integration Director, you will play a vital role in developing and implementing analytical/process strategies for selected projects within our Early-Stage project portfolio.
Your primary responsibilities will include:
- Developing and integrating new analytical/process strategies into our CMC Development Path.
- 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 our Project Managers in resolving CMC issues with a holistic approach, focusing on new antibody modalities or CMC challenges like transfer to new manufacturing sites.
- Authoring and reviewing regulatory CMC submissions, including IND/CTA.
- Ensuring compliance with Good Manufacturing Practice (GMP) and maintaining high-quality standards throughout the development process.
What We're Looking For
To succeed in this role, you should have:
- A strong background in Bioprocess Technology/Bioprocess Analytics, preferably with therapeutic monoclonal antibody or protein development and manufacture experience at clinical and/or commercial scale.
- Excellent knowledge of GMP principles and CMC development within the biopharmaceutical industry.
- At least 4-8 years of working experience with biopharmaceuticals, preferably in a similar role.
- Fluency in English, with knowledge of a Scandinavian language an asset.
- Basic knowledge of Project Management tools.
Why Choose Genmab?
We offer a dynamic work environment, opportunities for professional growth and development, and a competitive salary. The estimated annual salary for this position is approximately $120,000-$150,000, depending on your level of experience and qualifications.
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. With over 20 years of experience, we've developed next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
Our Commitment to Diversity, Equity, and Inclusion
We are committed to fostering workplace diversity at all levels of the company and believe it's essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
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