Vice President, Head of CMC Product Development

At Genmab, we are dedicated to building extra[not]ordinary® 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

We are seeking a highly motivated and experienced Head of CMC Product Development to lead and shape the CMC Product Development strategy and execution for our expanding portfolio of antibodies, ADCs, and bispecific biologics. The successful candidate will be responsible for overseeing all scientific and technical aspects of CMC development, including process development, analytical sciences, formulation, and technology innovation to support clinical development and commercialization.

This leadership role will collaborate cross-functionally with the rest of the TechOps organization as well as R&D, Regulatory, Quality and external partners to ensure robust, phase-appropriate CMC strategies are developed and implemented to meet program timelines, regulatory expectations, and business goals.

Responsibilities

Strategic Leadership

• Define and drive the CMC Product Development vision, strategy, and roadmap for early- to late-stage programs.

• Lead the integration of cutting-edge technologies for biologics manufacturing with a focus on reducing timelines to FIH and operation excellence, including high-throughput process development and next-generation analytical platforms.

• Serve as a key member of the TechOps Leadership Team.

• Evaluate new product candidates, new technologies and clinical assets from a CMC development perspective via relevant internal governance bodies.
  

CMC Development Oversight

• Oversee cell line development, upstream/downstream process development, and formulation development for monoclonal antibodies, bispecifics, and ADCs.

• Ensure robust and scalable manufacturing processes that meet quality, regulatory, and business requirements.

• Provide technical leadership on analytical method development, characterization, and comparability assessments.

Technology and Innovation

• Champion innovative technologies and scientific approaches to streamline CMC development and reduce timelines.

• Evaluate and implement novel expression systems, purification platforms, or conjugation chemistries tailored to complex biologics such as ADCs and bispecifics.

• Ensure a cutting-edge data and data systems strategy.

Regulatory Support

• Oversee the generation and delivery of high-quality technical source documents and data packages to support regulatory submissions (e.g., INDs, IMPDs, BLAs).

• Ensure that scientific documentation from CMC Product development is accurate, complete, and aligned with program objectives and regulatory requirements.

• Collaborate closely with Regulatory Affairs and TechOps to address regulatory questions and technical clarifications throughout the lifecycle of the program.

External Collaboration and CDMO Management

• Identify and manage strategic relationships with CDMOs, technology providers, and academic collaborators to augment internal capabilities.

• Ensure scientific and technical alignment between internal teams and external partners for successful project execution.

Team Leadership and Talent Development

• Lead and mentor a diverse, high-performing team of approximately 150 staff across four core departments.

• Drive organizational design, career development, succession planning, and a culture of scientific excellence and accountability.

• Promote collaboration, empowerment, and knowledge sharing across functions and development stages.

Requirements

• Ph.D. in Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field; advanced degree required.

• Minimum 15 years of biopharmaceutical industry experience with a strong background in CMC development.

• Proven track record of successful development of antibodies, ADCs, or bispecifics, from early phase to BLA/MAA.

• Deep understanding of regulatory expectations for complex biologics globally.

• Strong scientific acumen across biologics CMC disciplines (process, analytical, formulation).

• Excellent leadership, strategic thinking, and communication skills.

• Ability to thrive in a fast-paced and collaborative environment.

• Experience with platform development for antibody-based therapeutics.

• Familiarity with QbD, PAT, and CMC lifecycle management.

• Experience guiding organizations through growth or transformational change.

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 you’re 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X .

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) .

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the contract.