Senior CMC Stability Associate

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 pipeline is experiencing an exciting growth period! New projects are continuously feeding into preclinical development, while existing CMC projects are successfully advancing from First-in-Human trials to late-stage project development and market authorization approvals. To support this growth, we are looking for a passionate and experienced Senior CMC Stability Associate to join our CMC Stability team in CMC Operations.

If you have a background in or are familiar with stability testing and biologics, including reference standards, and want to be part of a team that is constantly evolving within a dynamic CMC organization, then this is the perfect opportunity for you.

Our team consists of nine skilled and dedicated employees. In addition to the CMC Stability Team, our department includes three other teams: two Project Manager Teams and a CMC Writer Team. Together, we work towards supporting CMC Operations and Genmab’s CMC projects. You will collaborate closely with your team members, the CMC Project Managers, and the CMC Management team to ensure that stability activities are managed compliantly and driven according to project timelines. You will engage with both internal stakeholders at Genmab and external collaborators, including CMOs.

This position reports to the Team Lead for the Stability team and is based in our Copenhagen Headquarters Office, Denmark.

Responsibilities

• Collaborate with CMC PMs, QA, and RA.

• Manage, collaborate, and oversee outsourced stability activities.

• Follow up timely on CMO stability testing performance.

• Address atypical/adverse stability results and trends with CMO.

• Handle stability data in iStability.

• Trend and oversee product stability performance.

• Manage stability protocols, interim stability data reports, and final stability reports.

• Set shelf-life.

• Align stability strategy with CMC PMs.

• Support authoring and review of CMC regulatory stability sections.

• Ensure compliance with Genmab’s Quality System and FDA, EMA, ICH, USP, and EP guidelines and regulations related to quality control of biological products.

Requirements

• A relevant scientific education at the master’s degree level or in a related technical area with a minimum of 2 years’ experience in the pharmaceutical industry.

• Experience working with biopharmaceutical and/or industry experience, preferably under GMP.

• Knowledge and understanding of stability testing for products in clinical development and for marketed products is an advantage.

Personal Attributes

• Ability to work successfully with enthusiasm and integrity in a fast-paced environment with tight timelines.

• Clear communication skills, both internally and externally, towards CMOs and other stakeholders.

• A team player with a demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support CMC development projects.

• A structured and systematic approach, an interest in basic statistics, and a flair for IT and user software to monitor stability.

• Self-motivated and able to work independently, with the capability to manage multiple tasks and prioritize work effectively. Ensure progress and take responsibility for agreed tasks and matters.

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. 

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