[Hiring] Senior CMC Specialist, Product Characterization @DK001 Genmab A/S
Apr 02, 2025 - DK001 Genmab A/S is hiring a remote Senior CMC Specialist, Product Characterization. 💸 Salary: unspecified. 📍Location: Europe, Denmark.
Role Description
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 Chain.
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
Qualifications
- 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
Requirements
- 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!
Benefits
- 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
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| 📍 | Be aware of the location restriction for this remote position: Europe, Denmark |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
unspecified
|
Remote
Location
Europe, Denmark
|
|
Job Type
full-time
|
Posted
Apr 02, 2025
|
| 📍 | Be aware of the location restriction for this remote position: Europe, Denmark |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
