Senior Specialist, CMC Drug Product

Senior Specialist, CMC Drug Product

Genmab

Copenhagen, Denmark

Responsibilities

With great energy, you will join Genmab’s growth journey and contribute with your drug product and/or Life Cycle Management experiences.

As a (Senior) Drug Product subject matter expert (SME), you will be responsible for the following:

• 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.  

Requirements

• 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.