Senior Director, Head of Department, CMC Late Stage & Development Project Management

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!

Senior Director Head of Late-Stage Manufacturing Development Project Management

Genmab Tech Ops Denmark

The Role and Department

To support Genmabs continued growth we are seeking a Senior Director Head of Department Late-Stage Manufacturing Development (LSMD) Project Management to join our expanding Late-Stage Manufacturing team.

The overall LSMD team is divided into the LSMD Project Management LSMD Process Development LSMD Protein Characterization & Analytics and the Pharmaceutical Development team. At Genmab the LSMD area is responsible for the late-stage development activities of Genmabs portfolio projects and preparation of the CMC package for regulatory filings.

In this role you will lead a growing team of 10 Project Managers and report directly to the Vice President Late-Stage Manufacturing Development within Genmab Tech Ops (Denmark).

This is a unique opportunity to both set direction for Genmabs CMC area and develop the team behind this effort.

Responsibilities

• Provide day-to-day leadership of the LSMD Project Management team including resource planning recruitment performance management and capability development
• Oversee CMC project strategy timelines and budgets across all LSMD-managed programs
• Lead strategic project management initiatives including ownership and continuous improvement of the LSMD Project Manual Contribute to LSMD strategic planning and ensure alignment across LSMD and the wider Tech Ops organization
• Ensure compliance with relevant regulatory guidelines and industry standards
• Support the maintenance and ongoing improvement of the CMC Operations quality system
• Collaborate cross-functionally with internal and external CMC stakeholders to drive integrated product development strategies

Requirements

• Masters degree or higher in natural sciences pharmacy engineering or a related field
  Minimum 1015 years of CMC experience within the pharmaceutical or biotechnology industry
• Demonstrated project management experience within a CMC or development environment
• Strong knowledge of global CMC regulatory requirements (e.g. FDA EMA NMPA)
• Proven experience contributing to CMC sections of regulatory submissions and interacting with global health authorities
• Prior people-management experience with a track record of developing and leading high-performing teams
• Excellent written and verbal communication skills in English

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.

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 ().