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 & Department
Genmab´s clinical pipeline is in an exciting growth period, and we are looking for a Senior Associate to join the CMC Stability team in Denmark.
While existing projects are successfully moving from First-in-Human trials to Late-Stage project development and market authorization approvals, new projects continuously feed into preclinical and early clinical development.
Currently the team exists of 8 skilled, and dedicated employees. Besides the Stability team, there are three more teams in the department, two project manager teams and a CMC writer team. All teams work towards supporting CMC Operations and the Genmab’s pipeline projects and the commercial product demand.
You will be performing your work in close collaboration with your closest colleagues in the team, the CMC Project Manager, and the CMC Management team, where you will ensure that the stability activities are compliantly conducted and executed according to project timelines. This means that your stakeholders and activities are both internally in Genmab but also with CMOs and external collaborators.
This position will report to the Team Lead for the Stability team. This role is located in Copenhagen, Denmark and is hybrid.
Responsibilities
The responsibilities of the Senior CMC Associate will include, but not be limited to:
Handle stability studies in partnership with Genmab QC, CMC PMs, QA and with CMOs, i.e., handle the stability protocols, stability data, final stability reports, and non-compliances
Responsible for continuous oversight of the stability profile, including trending and setting of shelf life / expiry date
Responsible for oversight of stability testing activities performed at Genmab and at CMOs
Support authoring of regulatory stability sections (e.g., for both clinical and commercial product) and when needed, participate in response rounds with Health Authorities
Be part of improving how we operate within the team and with our stakeholders
Requirements
You hold a relevant scientific education on the level of master’s degree or related technical area.
A background working within the pharma/biotech industry
Knowledge and understanding of stability testing for products in clinical development and e.g. for marketed products
Moreover, you meet the following personal requirements:
Able to work successfully, with enthusiasm and integrity in a fast-paced environment with tight timelines
A team player with a demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programs
You have a structured and systematic approach, flair for IT and user software to monitor stability.
Ability to manage multiple tasks, prioritize work
About You
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.
Arreoblue
FCamara Consulting & Training
Pragmatike
Matillion
Sitel Group