CMC Technical Integration Manager

6 days ago

Copenhagen, Copenhagen, Denmark Genmab AS Full time

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(Senior) CMC Technical Integration Manager

Locations: Copenhagen

Time Type: Full time

Posted on: Posted 2 Days Ago

Job Requisition ID: R11639

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

Genmab is now searching for two (Senior) CMC Technical Integration Managers to join the CMC Integration Team in New Product Introduction (NPI) CMC. The NPI CMC Team is responsible for the Early-Stage CMC development covering the preclinical to early/mid clinical stage CMC work. The NPI team is part of CMC Operations in Copenhagen, which is over 100 employees. CMC Operations is responsible for development and manufacture of Genmab antibody drugs used in preclinical, clinical, and commercial settings.

As (Senior) CMC Technical Integration Manager, you will be developing and supporting the required analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio. You will integrate these strategies into projects where the CMC development path is deviating from the Genmab CMC platform and where specific adaptations are required to ensure technical excellence, regulatory compliance, and speed into First-in-Human trials. Typical programs will cover projects transitioning from Discovery/Research into regular CMC development towards first-in-human studies. The scope of work also covers new modalities such as Antibody Drug Conjugates, more complex and new antibody formats, or specific program challenges from an analytical/process perspective including e.g. transfer of existing programs to new manufacturing/testing sites.

You should bring a broad background from CMC development within Bioprocess Technology/Bioprocess Analytics. You will work as part of the CMC Management Team of specific CMC development programs and will act as a first line of contact for the CMC PM team for resolving CMC issues. You will report to Associate Director CMC, Team Lead CMC Integration.

If you are rooted in CMC process or analytical science of large recombinant proteins or monoclonal antibodies and wish to develop on a path to CMC Project Management, this position could be the perfect match for your personal development.

Key Responsibilities Include

  • Integration of new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
  • Managing specific analytical/process activities at CMOs related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
  • Support the CMC PM 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.
  • Support authoring and reviewing of regulatory CMC submissions (IND/CTA).
  • Supporting and following up on CMO and internal quality events such as changes or deviations.
  • You have a proven track record and the technical skills of biological process or analytical development and biopharmaceutical manufacturing.
  • Very good knowledge of the principles of GMP and CMC development within the biopharmaceutical industry.
  • At least 4-8 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale.
  • Additional experience from antibody drug conjugate projects or chemical engineering/API technology or new antibody formats is an advantage.
  • Fluent in English and (preferably) knowledge of a Scandinavian language.
  • As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture of investigational drugs, experience in running projects with external partners is preferred.
  • You have basic knowledge of Project Management tools.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
  • 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 experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

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. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our Commitment to Diversity, Equity, and Inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is 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. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

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