Senior CMC Specialist, Drug Linker

Senior CMC Specialist, Drug Linker

Genmab

Copenhagen, Denmark

The Role and Department

As (Senior) CMC Specialist, Drug Linker you will join the experienced Late-Stage Manufacturing Development (LSMD) department, working on late-phase development activities for portfolio projects and preparing CMC packages for regulatory filings in a dynamic international environment. 

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. With great energy, you will join Genmab’s growth journey, contributing your experience and knowledge in chemical manufacturing.

Responsibilities

• 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.

Requirement

• The ideal candidate holds a degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or another relevant field,
• At least 3+ years of experience in the synthetic API manufacturing processes in CMC area, preferably from Late-Stage Development.
• 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 designing and evaluating DoE experiments is preferred.
• Experience in preparing and reviewing relevant filing documentation for regulatory market authorizations is preferred.
• Focused on achieving goals important to the team and the organization.
• Proactive and strategic mindset with a desire to continuously develop and find innovative solutions.
• Well-organized, with the ability to plan, execute, and meet deadlines.
• Ability to work successfully under pressure in a fast-paced environment with tight timelines.
• Open-minded, dedicated, and flexible, utilizing high energy and a can-do attitude to proactively handle various tasks.
• Strong communication skills, with excellence in English, both written and verbal.

You are focused on achieving goals that are important for the team and the organization. You have a proactive mindset and a desire to continuously develop and find innovative solutions. In addition, you are well-organized, and can plan, execute, and meet deadlines. You have the ability to work successfully under pressure in a fast-paced environment and with tight timelines.

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!

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