Senior CMC Specialist, Drug Linker Development

Senior CMC Specialist, Drug Linker Development

Genmab

Copenhagen, Denmark

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.

Key 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:

The ideal candidate holds a degree in Chemistry, Organic Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant field, and has at least 6 years of documented professional experience within synthetic API manufacturing, process chemistry, drug linker development, or a related CMC area.

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

Furthermore the successful candidate will have the following profile:

• Strong experience in synthetic organic chemistry and synthetic API manufacturing processes;
• Experience with drug linker, payload linker, chemical intermediate or ADC-related development is preferred;
• Understanding of bioconjugation techniques is preferred;
• Thorough understanding of late-stage CMC development activities, including process characterization, risk assessment, process validation, and process performance qualification;
• Experience with definition of starting materials, specified impurities, reference standards, intermediate specifications, and final API specifications;
• Experience preparing and reviewing technical documentation, including development reports, technology transfer reports, process characterization reports, batch records, and regulatory documentation;
• Experience designing, evaluating and documenting DoE studies is preferred;
• Experience preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred;
• Experience working with CMOs and external partners is preferred;
• Ability to independently drive drug linker CMC activities, provide expert input to project teams and represent drug linker development in cross-functional discussions;
• Strong communication skills, with excellence in English, both written and verbal.

Moreover, you meet the following personal requirements:

• You are focused on achieving goals that are important for the team and the organization;
• You have a proactive and strategic mindset with a desire to continuously develop and find strong solutions;
• You are well organized and able to plan, execute and meet deadlines;
• You have the ability to work successfully in a fast-paced environment with tight timelines;
• You are open-minded, dedicated, and flexible, with a can-do attitude and the ability to proactively handle various tasks;
• You enjoy working across functions, sharing knowledge, asking questions and contributing to solutions through collaboration.