Senior CMC Specialist, Product Characterization
Posted 20 hours 2 minutes ago by Genmab
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.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role & Department
The Genmab CMC Late Stage Manufacturing Development (LSMD) Team is looking for a Product Characterization Senior CMC Specialist. The LSMD Team is responsible for the Late-Stage Development activities of Genmab's portfolio projects and Scientific Support to the Commercial Supply Shain.
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!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
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 and follow us on LinkedIn and X .
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