CMC Project Manager

at  Genmab

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 continues to grow and are now searching for one more 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. You will report to the Associate Director, Team Lead, New Product Introduction embedded in CMC Operations, Copenhagen.
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
• Additional experience from either antibody drug conjugate projects or chemical engineering/API technology would be an asset
• Fluency in English.
• 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

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
https://www.genmab.com/privacy

• 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 governanc