Senior Specialist, CMC Stability

Genmab; København; On-site; DKK 624,000 - 936,000; Full time

Benefits offered by this job

Pension

Health insurance

Paid time off

Employee support programs

Job summary

Genmab is seeking a CMC Senior Stability Specialist in Copenhagen to strengthen the CMC Stability department. You will drive stability activities, govern product stability, and collaborate across CMC, QA, Regulatory Affairs, Drug Supply, and external partners in a highly matrixed, international environment.

The role requires extensive biologics stability experience, statistical data handling, and the ability to translate complex data into regulatory and business recommendations.

Qualifications

• PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or related discipline.
• 7+ years of experience in CMC stability for biologics.
• Strong knowledge of ICH guidelines, including Q1A–Q1E, Q5C, and Q6B.
• Experience with statistical methods applied to stability data (regression analysis, pooling, trend analysis).
• Experience working with CDMO’s/CMO’s.
• Experience with supporting global regulatory submissions.
• Ability to translate complex scientific and statistical data into clear regulatory and business recommendations.

Responsibilities

• Act as stability subject matter expert supporting Genmab’s biologics products.
• Ensure alignment and oversight of stability activities performed at external partners, CDMO’s/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 data handling, trend analysis and shelf-life determination.
• Author and review CMC sections of regulatory submissions (IND, CTA, BLA/MAA, variations).
• Support health authority interactions, e.g. be part of the request for information processes for topics related to stability.
• Be part of establishing a mature life-cycle-management set-up for commercial products.

Skills

CMC Stability

Statistical analysis

ICH guidelines

CDMO/CMO experience

Regulatory submissions

Biologics stability

Education

PhD or MSc in pharmaceutical sciences or related discipline

Tools

Statistical software

Data analysis tools

Job description

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.

At Genmab, we are dedicated to transforming the lives of patients through innovative antibody-based medicines. To support our biologics pipeline and portfolio, we are looking for a CMC Senior Stability Specialist in the CMC Stability department to strengthen our CMC organization with a focus on life-cycle-management activities.

As CMC Senior Stability Specialist, you will be part of the CMC Stability department organized in CMC Development and Manufacturing. The CMC Stability department supports the Genmab portfolio from early CMC development projects to commercial products. Additionally, you will be part of and collaborate with CMC project teams.

You will join a department of eight skilled and dedicated employees. In the role, you will be responsible for stability, governance of products and collaborate closely with colleagues within the department, across CMC, Quality Assurance, Regulatory Affairs, Drug Supply, and with external partners at CDMO’s/CMO’s in a highly matrixed, international environment.

Besides having extended experience with biologics and stability, the ideal candidate is statistically well-founded and can help advance the department’s data-handling capabilities.

This position will report to the Head of Department, CMC Stability.

Responsibilities

• Act as stability subject matter expert supporting Genmab’s biologics products.
• Ensure alignment and oversight of stability activities performed at external partners, CDMO’s/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 data handling, trend analysis and shelf-life determination.
• Author and review CMC sections of regulatory submissions (IND, CTA, BLA/MAA, variations).
• Support health authority interactions, e.g. be part of the request for information processes for topics related to stability.
• Be part of establishing a mature life-cycle-management set-up for commercial products.

Requirements

• PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or related discipline.
• Significant experience (typically 7+ years) within CMC stability for biologics and strong knowledge of ICH guidelines, including Q1A–Q1E, Q5C, and Q6B.
• Extensive knowledge and understanding of stability for marketed biologics/clinical biological products according to current requirements and best industrial practices.
• Demonstrated knowledge and experience in statistical methods applied to stability data (e.g. regression analysis, pooling, trend analysis).
• Experience working and interacting with CDMO’s/CMO’s.
• 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 seek and have 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 department goals.
• You can work successfully and with integrity in a fast-paced environment with tight timelines.

What You Can Expect At Genmab

• A high-impact role in a science-driven organization focused on patients.
• A collaborative and inclusive culture with strong cross-functional teamwork.
• Opportunities to shape strategy and contribute to key project decisions.
• Professional growth in a global biologics company with a strong pipeline.

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK624.000,00---936.000,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

Benefits

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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 Job Applicant Privacy Notice (genmab.com).