Genmab
CMC Senior Analytical & Characterization Specialist
DanmarkPosted 8 days ago
Full TimeSeniorDK
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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 t
Key Highlights
- CMC Project Managers.
- MSAT colleagues across CMC Process Development, CMC Stability, CMC Pharmaceutical Development, and CMC Writing.
- Cross-functional stakeholders in Quality, CMC Regulatory, Product Development (our non-GMP CMC development lab in Utrecht, NL), and Genmab QC (Ballerup, DK).
- External partners, including Contract Manufacturing Organizations in a network across the globe (CMOs).
- Lead and manage analytical method strategies, including development, qualification, validation, transfer, and lifecycle management for e.g. biologics, conjugated therapeutics.
Qualifications
Required Qualifications
- Master’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific field (PhD preferred).
- 8–10+ years of experience within CMC Analytical Development, MSAT, or a related GMP regulated area in the pharmaceutical or biotechnology industry.
- Strong expertise in setting up robust analytical methods at CMOs and external laboratories, validation, and characterization for biologics and/or conjugated therapeutics.
- Hands-on experience with ADC analytical characterization, including knowledge of: Small molecule payloads Linker chemistry Conjugation strategies Impurity characterization
- Small molecule payloads
- Linker chemistry
- Conjugation strategies
- Impurity characterization
- Experience working across both large molecule and small molecule analytical disciplines is highly preferred.
- Familiarity with analytical techniques relevant to ADCs and complex biologics, such as CEX, CE-SDS, SEC, icIEF, peptide mapping, and related characterization methods.
- Experience with regulatory documentation and submissions (e.g., BLA, MAA), including analytical and characterization sections supporting late-stage development and commercialization.
- Excellent communication skills in English, with the ability to engage effectively across functions, cultures, and external partners.
About the Company
Genmab
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
Danmark
Posted
8 days ago
Country
DK