Senior CMC Project Manager

Senior CMC Project Manager

Genmab

Copenhagen, Denmark

As the CMC Life-cycle and Commercial Project Manager, you’ll oversee Genmab’s commercial programs, coordinating and planning activities with our partnered CMOs. You’ll collaborate closely with colleagues in LSMD, the commercial supply chain, regulatory affairs, and QA to ensure seamless operations.

Responsibilities

• Provide day-to-day support for commercial manufacturing activities at Genmab’s partnered CMOs or partner companies;
• Manage commercial commitments to various health authorities;
• Support and follow up on CMO and internal quality events, such as changes or deviations;
• Further develop LCM activities and ways-of -working;
• Maintain the quality system of CMC Operations;
• Coordinate and manage projects with external partners, as Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture;
• Manage establishment of a LCM project group within LSMD.

Requirements

• Master’s degree in relevant natural sciences;
• 7+ years of experience in biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development;
• 7+ years of experience in CMC project management;
• Proven track record in biological process development/biopharmaceutical manufacturing;
• Experience with the CMC technical sections of regulatory submissions and interacting with global regulatory authorities;
• Excellent communication skills in English and the ability to work in multicultural teams;
• Ability to manage multiple tasks, prioritize work, and achieve project and team goals;
• Team player with the ability to collaborate with diverse stakeholders;
• Result- and goal-oriented, committed to contributing to Genmab’s success.

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!