CMC Specialist, Stability

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

As CMC Stability Specialist you will be part of the CMC Stability team organized in the CMC area, additionally, you will be part of and collaborate with CMC project teams.

You will join a small team of skilled and dedicated employees. The team supports the Genmab portfolio from early CMC development to commercial products.

In this role, you will have the responsibility of stability governance of Genmab products. You will collaborate closely with colleagues in the team, across CMC, Quality, Regulatory Affairs, Drug Supply, and with external partners at CMO's in a highly matrixed, international environment.

This position will report to the CMC Stability team lead.

Key Responsibilities

• Act as stability matter expert supporting Genmab's biologics pipeline.
• Ensure alignment and oversight of stability activities performed at external partners, CMO's, and internal laboratories.
• Ensure scientifically sound and regulatory-compliant stability approaches aligned with ICH guidelines and regulations.
• Perform and oversee statistical evaluation of stability data, including trend analysis and shelf-life determination.
• Author and review CMC sections of regulatory submissions (IND, CTA, BLA/MAA, variations).
• Support health authority interactions and responses related to stability.
• Be part of setting up the life cycle management of stability support for commercial products practices.

• PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or related field.
• Significant experience (5+ years) within CMC stability for biologics.
• Extensive knowledge and understanding of stability testing for products in clinical development and/or marketed Biologics according to current market and best industrial practices.
• Demonstrated knowledge and interested in statistical methods applied to stability data (e.g. regression analysis, pooling, trend analysis).
• Strong knowledge of ICH guidelines, including Q1A-Q1E, Q5C, and Q6B.
• Experience with supporting global regulatory submissions.
• Ability to translate complex scientific and statistical data into clear regulatory and business recommendations.

• You can work successfully and with integrity in a fast-paced environment with tight timelines.
• You are a Team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programs.
• You have a structured and analytical approach when solving problems.
• Flair for IT and user software to monitor stability.
• You can manage multiple tasks, prioritize work, and define steps needed to achieve project and team goals.

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can 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!