CMC Specialist, Stability

CMC Specialist, Stability

Genmab

Copenhagen, Denmark

The Role

As a CMC Stability Specialist, you will be part of the CMC Stability team organized within 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 responsibility for the 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 CMOs in a highly matrixed, international environment.

This position will report to the CMC Stability Team Lead.

Key Responsibilities

• Act as stability subject 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.

Qualifications and Experience

• PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or related discipline;
• Significant experience (typically 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.

Moreover, you meet the following personal requirements

• You can work successfully and with integrity in a fast-paced environment with tight timeliness;
• 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.

About You

• 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!