Senior Stability Scientist - Biologics CMC

Genmab; København; Sur place; DKK 624 000 - 936 000; Plein temps

Avantages offerts par ce poste

Pension

Health insurance

Paid time off

Employee support programs

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CMC Stability

Statistical analysis

ICH guidelines

CDMO/CMO experience

Regulatory submissions

Biologics stability

Formation

PhD or MSc in pharmaceutical sciences or related discipline

Outils

Statistical software

Data analysis tools

Description du poste

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.