Senior Specialist, CMC Drug Product

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

Do you want to work as one team? Share knowledge, be curious, ask questions, and learn new things to achieve goals and meet ambitious deadlines?

You will be rewarded by focusing on teamwork and achieving outstanding results through and with your team.

You will be part of Manufacturing Science & Technology (MSAT) within CMC Development & Manufacturing, contributing to late-stage development activities across portfolio projects and preparing CMC documentation for regulatory filings in a stimulating international environment.

If you recognize yourself in this description, you might be the right choice as our (Senior) Specialist, CMC Drug Product we are looking to hire to support Genmab's expanding portfolio and continued global growth.

The position is placed in the CMC Pharmaceutical Development. CMC Pharmaceutical Development is part of MSAT and is responsible for Drug Product late-stage development, validation and manufacturing activities as well as Life-Cycle management activities. The department currently consists of 7 people and is expanding. You will report to the Head of CMC Pharmaceutical Development.

• Drug Product (DP) activities performed at Genmab's partnered CMOs and work across project teams to support the CMC Project.
• Overseeing DP activities incl manufacturing campaigns performed at partnered CMOs, including troubleshooting, process characterization, tech transfer and process performance qualification.
• Support drug product batch manufacturing by review of protocols, master batch records and executed batch records thereby supporting release of clinical and commercial batches for one or more of our late-stage projects.
• The right candidate will potentially also be assigned responsibilities within DP late stage development activities, incl. in-use compatibility studies and line extension activities for drug product (potentially new formulations or other changes).
• Authoring and reviewing CMC regulatory submission documents.
• Supporting the definition and refinement of required processes for late-stage / LCM DP activities.
• You will work closely with other SME's and project managers for e.g. late-stage drug product development, as well as our commercial supply chain colleagues, regulatory affairs and QA.

• Master's degree in science, pharmacy, or a related technical area .
• 7+ years of experience in CMC or related area in pharmaceutical, biotechnology, and/or medical device industry, preferable within life-cycle management of product or commercial manufacturing.
• Experience with late-stage development and commercialization of biologic drug products .
• Thorough understanding and overview of aseptic drug product processes, experience from manufacturing and/or development of biological drug products (liquid and/or freeze-dried drug products) with in-depth knowledge of, risk assessment, and late-stage validation activities.
• Experience with regulatory documentation including regulatory commitments, experience with quality documentation according to Good Manufacturing Practice.
• Ability to write and review documentation for regulatory market authorizations (e.g., BLA, MAA) and clinical trial applications.
• Excellent communication skills in English (both written and oral) and the ability to work in multicultural teams.
• Ensure compliance with applicable regulatory guidelines and industry standards.
• Travel can be expected.
• Goal-oriented with a focus on achieving outcomes important to the team and organization.
• Proactive, taking initiative and responsibility in a fast-paced environment.
• You have the ability to work successfully under pressure with tight timelines.
• Team player capable of collaborating with a diverse group of internal and external stakeholders.

• 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!