Senior CMC Specialist, Drug Linker Development

About the role

Do you want to join our highly talented Process Development team within MSAT CMC Operations and work closely with late-stage development activities in a stimulating international environment? With Genmab's continued growth, we work with strong engagement to support late-stage development activities across portfolio projects and prepare high-quality CMC packages for regulatory filings. We are now looking for a Senior CMC Specialist, Drug Linker Development , to join our journey and contribute with strong process chemistry and API manufacturing expertise. You will be part of Process Development in MSAT. Process Development is responsible for Upstream, Downstream, and Drug Linker processes. The function currently consists of 16 people and is expanding. You will report to the Director, Head of Process Development. Do you want to work as a 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 creating strong results through and with your team. In this role, you will: Contribute to a pioneering company with an innovative and expansive growth strategy. Make a difference in people's lives through future cancer treatments. Leverage your expertise in organic chemistry and synthetic API manufacturing to contribute to antibody-drug conjugate, ADC, development. Help define strategies for payload linker and drug linker processes across late-stage CMC projects. The Challenge As the Senior Drug Linker Subject Matter Expert, SME, you will be responsible for activities related to chemical intermediates, payload linkers, and drug linkers used in ADC development at Genmab's partnered CMOs. You will work across project teams to support the CMC Project Managers and collaborate closely with other SMEs in areas such as downstream processing, analytical methods, characterization, quality, and regulatory CMC. With strong drive and engagement, you will join Genmab's growth journey and contribute with your experience and knowledge within organic chemistry, synthetic API manufacturing, and late-stage CMC development.

Responsibilities

• Develop and implement late-stage development strategies for chemical intermediates, payload linkers, and drug linkers.
• Define the scope for late-stage drug linker development activities in collaboration with CMOs and partners, in line with current industry standards and regulatory guidance.
• Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, process validation and process performance qualification.
• Contribute to the definition of starting materials, specified impurities, reference standards, specifications for intermediates and final API.
• Support evaluation of process performance, process parameters, deviations, change controls, manufacturing trends and process robustness.
• Prepare and review technical documentation, including development reports, technology transfer reports, process characterization reports, process validation documentation, batch records and SOPs.
• Author and review CMC regulatory submission documents and responses to health authority questions.
• Cross collaborate with CMC colleagues to implement ADC development strategies and control.
• Support the definition, implementation and continuous improvement of internal processes related to drug linker activities.
• Contribute to continuous improvement of CMC strategies, ways of working and collaboration with external partners

Requirements

• Experience from late-stage development, process characterization, process validation, regulatory CMC activities, or external manufacturing support is preferred.
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Benefits

Additional Information

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!

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