Senior CMC Project Manager

4 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. 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 & Department
Genmab is now searching for a Senior Project Manager CMC to join the Late-stage Manufacturing Development (LSMD) Team in Copenhagen.

The LSMD CMC Team is part of CMC Operations in Copenhagen, which now has close to 100 employees. CMC Operations is responsible for development and manufacture of Genmab antibody drugs used in preclinical, clinical, and commercial settings. The Late-Stage Manufacturing Development Team is responsible for process characterization and process validation activities and submitting market authorization applications.

As CMC Project Manager, you will support the CMC Lead of one of Genmab's late stage development programs and you will be responsible for the coordination and planning of activities performed at our partnered CMO's. In doing so you will work closely with SMEs for e.g. upstream/downstream processing, analytical validation and characterization and you will ensure that Genmab's products going through late stage development activities will be performed according to latest industry standards and regulatory guidance.

The CMC LSMD team at Genmab currently employs 25 people and you will report to the Team Lead of project managers in LSMD.

Key responsibilities include

  • Managing CMC activities at CMOs especially related to Drug Product manufacturing
  • Internal alignment in the CMC Management Team governing a CMC program within Genmab
  • Support the CMC Lead for strategy and execution of CMC late stage development activities towards BLA/MAA
  • Support authoring and reviewing of regulatory CMC submissions (BLA, MAA, JNDA)
  • Supporting and follow up on CMO and internal quality events as e.g. changes or deviations
  • Supporting the maintenance of CMC Operations' quality system

Requirements

  • At least 3-5 years of experience within CMC project management
  • At least 3-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale
  • You have a proven track record and the technical skills of biological process development and biopharmaceutical manufacturing
  • As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture, experience in running projects with external partners is preferred
  • GMP knowledge and insight into regulatory requirements as well as understanding of CMC principles and industry practices for biopharmaceuticals.
  • Excellent communication skills in English, written and oral.

Moreover, it is expected, that you have following:

  • Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals and team goals.
  • Ability to work successfully under pressure in an agile biotech environment with tight timelines
  • You are a team player with the ability to collaborate with a diverse group of internal and external stakeholders
  • You have a quality mindset.
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.
  • You are curious and like to challenge existing processes.
  • You are proactive and open-minded.
  • You are organized with a sense of detail.

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

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, which has resulted 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 here .

Location: Copenhagen - Carl Jacobsens Vej 30

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