Senior CMC Specialist, Product Characterization

Senior CMC Specialist, Product Characterization

Genmab

Copenhagen, Denmark

As the Product Characterization Senior CMC Specialist you will be part of a highly dedicated and specialized CMC team leading the Late Stage Manufacturing Development activities of Genmab’s proprietary Antibody Pipeline Programs towards marketing approval (BLA/MAA). You will work across project teams to support the CMC Project Managers and work closely with other specialists within upstream/downstream processing, analytical methods and drug product manufacture, as well as with relevant specialists within partner programs and areas.

This position reports to Associate Director, Team Lead, Late Stage Manufacturing Development, based in Copenhagen.

Key Responsibilities Include

• Development and implementation of the LSMD analytical and characterization strategy for ongoing projects;
• Day-to-day oversight of characterization activities performed at Genmab partnered CMOs and internal Genmab laboratories;
• Prepare and review technical documents and author regulatory submission documents;
• Collaborate with other areas to develop late-stage analytical/characterization strategies and refine required processes;
• 5-10 days of travel per year are expected.

Requirements

• Master's degree in science, pharmacy, or a related technical area; advanced degree or certification preferred;
• Minimum of 8 years of experience in CMC or a related area within the pharmaceutical or biotechnology industry;
• Solid background within characterization principles and methods for biologics, and preferably also antibody-drug-conjugates (ADC) and small molecule drugs. Advanced skills within LC-MS or chromatographic techniques are preferred;
• Thorough understanding of antibody functionalities, drug-conjugates as well as linker/payload, and their link to critical quality attributes in intermediates and drug product.
• Ability to author and review documentation for regulatory market authorizations (e.g., BLA, MAA);
• Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams.

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!

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