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CMC Operations Specialist
1 week ago
Genmab's Late-Stage Manufacturing Development (LSMD) team in Copenhagen is seeking a seasoned CMC Operations Specialist to join our dynamic team. As the CMC Life-cycle and Commercial Project Manager, you will play a critical role in ensuring the smooth operation of our commercial programs.
About the Role:You will work closely with our commercial supply chain, subject matter experts, regulatory affairs, and QA teams to ensure seamless operations. With a growing portfolio of commercial products worldwide, we're expanding our life-cycle management capabilities within the LSMD team.
As the successful candidate, you will provide day-to-day support for commercial manufacturing activities at Genmab's partnered Contract Manufacturing Organizations (CMOs) or partner companies. You will manage commercial commitments to various health authorities, support and follow up on CMO and internal quality events, and maintain the quality system of CMC Operations.
You will also coordinate and manage projects with external partners, as Genmab primarily uses CMOs for development and GMP manufacture. Your experience in biopharmaceutical, preferably with therapeutic monoclonal antibody or protein development, will be invaluable in this role.
About You:We are looking for a detail-oriented and organized professional who is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through innovative cancer treatment.
You should be a collaborative team player who can work effectively in a fast-paced environment, with excellent communication skills in English and the ability to work in multicultural teams. You must also have the ability to manage multiple tasks, prioritize work, and achieve project and team goals.
