Denmark Job Openings

Genmab

(Senior) Project Manager CMC

Copenhagen

FULL TIME

September 9, 2024

At Genmab, we’re committed to building extra[not]ordinary 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

Genmab is now searching for a (Senior) Project Manager CMC to join the New Product Introduction (NPI) CMC Team in Copenhagen.

The (NPI) CMC Team is part of CMC Operations in Copenhagen, which is now over 100 employees. CMC Operations is responsible for development and manufacture of Genmab antibody drugs used in preclinical, clinical and commercial settings.

As responsible CMC PM, you will be generating and executing the overall CMC strategy and planning within selected projects from the Genmab portfolio. The CMC PM will be part of a team of CMC PMs supported by specialists for e.g. assay/process development, product characterization and Fill Finish. The CMC department at Genmab currently employs more than 60 people and you will report to Associate Director, Team Lead, New Product Introduction.

Responsibilities

The responsibilities will include, but not be limited to:

Overall responsible for strategy and execution of CMC development towards CTA/IND and clinical proof of concept
Managing CMC activities at CMOs and supervision of internal process and assay development work
Internal alignment in the CMC Management Team governing a CMC program internally
CMC representative in the Compound Development Team
Authoring and reviewing regulatory CMC submissions
Supporting and follow up on CMO and internal quality events as e.g. changes or deviations
Supporting the maintenance of CMC Operations’ quality system
Budget oversight, project planning and internal governance

Requirements

You have a proven track record and the technical skills of biological process development and biopharmaceutical manufacturing
Experience within CMC project management is required
GMP understanding and understanding of CMC principles, industry practices within the field of expertise
At least 4-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture at clinical and/or commercial scale. For a Senior CMC Project Manager Position, you bring at least 8-10 years of relevant experience in the biopharmaceutical industry
Preferably you have experience with transferring the production of monoclonal antibodies or other large molecules between different sites and CMOs
Additional experience from either antibody drug conjugate projects or chemical engineering/API technology would be an asset
Fluency in English. Good understanding of Mandarin would be an asset, but is not a must
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.

Moreover, you meet the following personal requirements:

Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals.
An independent work-approach and good at building solid professional relations to collaborators and business partners.
You have a quality mindset
You are organized with a sense of details
You are result- and goal-oriented and committed to contributing to the overall success of Genmab
You find it comfortable to work in an agile biotech environment
You are curious and like to challenge existing processes
You are proactive and open minded

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

Job Applicant Privacy Notice (genmab.com)

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