Senior CMC Project Manager

At Genmab we are dedicated to building extranotordinary futures together by developing antibody products and groundbreaking knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create champion and maintain a global workplace where individuals unique contributions are valued and drive innovative solutions to meet the needs of our patients care partners families and employees.

Our people are compassionate candid and purposeful and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes our work is incredibly serious and impactful but we have big ambitions bring a ton of care to pursuing them and have a lot of fun while doing so.

Does this inspire you and feel like a fit Then we would love to have you join us!

The Role & Department

Are you ready to join our dynamic Late-Stage Manufacturing Development (LSMD) team in Copenhagen as our new Senior CMC Project Manager

At Genmab were experiencing rapid growth and are committed to enhancing our late-stage and commercial products. We need your expertise in late-stage and life-cycle management to help us on this exciting journey!

In this role youll work closely with our commercial supply chain subject matter experts regulatory affairs and QA teams. The LSMD team is responsible for the late-stage development of Genmabs portfolio projects and providing scientific support to the commercial supply chain. With a growing portfolio of commercial products worldwide were expanding our life-cycle management capabilities within the LSMD team.

As the CMC Life-cycle and Commercial Project Manager youll oversee Genmabs commercial programs coordinating and planning activities with our partnered CMOs. Youll collaborate closely with colleagues in LSMD the commercial supply chain regulatory affairs and QA to ensure seamless operations.

Join our talented team of 30 plus professionals in LSMD and report directly to the LSMD Project Management Team lead. This role is located in Copenhagen Denmark.

Responsibilities

• Provide day-to-day support for commercial manufacturing activities at Genmabs 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

• Masters 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 Genmabs 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!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years its hard-working innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational quantitative and data sciences resulting in a proprietary pipeline including bispecific T-cell engagers antibody-drug conjugates next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999 Genmab is headquartered in Copenhagen Denmark with international presence across North America Europe and Asia Pacific. For more information please visit and follow us on LinkedIn and X.

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