Senior Specialist, CMC Drug Product

At Genmab, we are dedicated to building extraordinary 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.

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.