Senior CMC Analytical specialist

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

Do you want to join our highly talented team of late-stage product characterization and analytics specialists in Copenhagen? With Genmab's continuous maturation, we work with great energy to prepare the CMC package for regulatory filings, and we need you to join in our amazing journey and contribute with your experience on analytical methods for small molecules and peptides

Late Stage Manufacturing Development is responsible for the late-stage development activities of Genmab's portfolio projects and preparation of the CMC package for regulatory filings. As the (senior) analytical specialist, will work across project teams to support the project managers and work closely with other specialists e.g. upstream processing, downstream processing, and characterization as well as external stakeholders.

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

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

• You have a thorough understanding of the detailed requirements for analytical validation and requirements for small-molecule / peptide analytics.

• 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

Professional Qualities:

• Goal-oriented with a focus on achieving outcomes important to the team and organization

• Proactive, taking initiative and responsibility in a fast-paced environment

• Strong ability to work under pressure with tight timelines

• Team player capable of collaborating with a diverse group of internal and external stakeholders

This role is located in Copenhagen, Denmark and is hybrid.

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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