Senior Specialist, CMC Stability

Genmab · Capital, Denmark

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Role summary

Genmab seeks a CMC Senior Stability Specialist to support biologics products through development and commercialization. The role focuses on stability oversight, statistical analysis, regulatory compliance, and lifecycle management within a collaborative CMC department.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Phenom, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-03 (originally posted 2026-10-03). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

PhD or MSc in pharmaceutical sciences, chemistry, biochemistry, statistics, or related field
7+ years CMC stability experience for biologics with deep ICH guideline knowledge
Expertise in stability for marketed biologics and current industrial best practices
Proficiency in statistical methods for stability data analysis and shelf-life determination
Experience collaborating with CDMOs, CMOs, and global regulatory submissions
Ability to translate complex scientific data into clear regulatory recommendations

What you'll be doing

Serve as stability subject matter expert for Genmab's biologics portfolio
Oversee and ensure alignment of stability activities at external partners and internal laboratories
Perform statistical evaluation of stability data including trend analysis and shelf-life determination
Author and review CMC sections for regulatory submissions including IND, CTA, and BLA/MAA applications
Support health authority interactions and establish lifecycle-management processes for commercial products

CompensationDKK 624,000–936,000 base annual salary

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Date posted1 day ago

Last source checkToday

Salary listedNeeds clarity

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