Senior CMC Specialist

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department

Are you driven by sharing knowledge, staying curious, asking questions, and learning new things to achieve ambitious goals and meet tight deadlines? At Genmab, your focus on teamwork and delivering exceptional results with your colleagues will be highly rewarded. If this sounds like you, you could be the next brilliant Senior CMC Specialist, Antibody-Drug Conjugate, supporting our expanding portfolio and contributing to our continued global growth.
 

Our Late-Stage Development (LSMD) team works on advanced late-phase development activities and prepares the CMC package for regulatory filings in an exciting international environment. The team currently consists of 9 dedicated members – and we are looking to add more talented colleagues.

As the Senior Subject Matter Expert (SME) for drug linkers, you will be responsible for overseeing activities related to the chemical intermediates used in ADC development at Genmab’s partnered CMOs. You will work across project teams to support the CMC Project Manager and collaborate closely with other SMEs in areas such as downstream processing, analytical methods, and characterization.

The deadline is the 2nd of September, but we will be reviewing applications and conducting interviews on an ongoing basis.

Key responsibilities include

• Develop and implement late-stage development strategies for chemical intermediates (payload linkers).
• Define the scope for late-stage drug linker development activities in collaboration with our CMOs and partners, adhering to the latest industry standards and regulatory guidance.
• Oversee development and manufacturing activities performed at partnered CMOs, including troubleshooting, process characterization, and process performance qualification.
• Contribute to the definition of starting materials, specified impurities, specifications for intermediates and final API.
• Prepare and review technical documents including development, tech transfer, and process characterization reports, as well as batch records.
• Author and review CMC regulatory submission documents.
• Collaborate with downstream SMEs to develop and align late-stage ADC development strategies.
• Support the definition and refinement of required processes for drug linker activities.

Requirements

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or equivalent.
• Proven experience in the synthetic API manufacturing processes in CMC area.
• Extensive experience in synthetic organic chemistry and preferable bioconjugation techniques.
• Thorough understanding and overview of synthetic API manufacturing processes with in-depth knowledge of process characterization, risk assessment, and late-stage validation activities.
• Experience with definition of starting materials, impurities, reference standards (for API and impurities).
• Experience with designing and evaluating DoE experiments is preferred.
• Experience in preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.
• Excellent communication skills in English, both written and verbal.

Moreover, it is expected, that you have following:

• Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals and team goals.
• Ability to work successfully under pressure in an agile biotech environment with tight timelines
• You are a team player with the ability to collaborate with a diverse group of internal and external stakeholders.
• You have a quality mindset.
• You are result and goal-oriented and committed to contributing to the overall success of Genmab.
• You are curious and like to challenge existing processes.
• You are proactive and open-minded.
• You are organized with a sense of detail.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a genero