Engineering Design Director, US Biopharma Facility

Genmab; København; On-site; DKK 1,500,000 - 1,900,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab, based in Denmark, seeks a Sr. Director, Engineering Design to lead the establishment of Genmab’s first internal manufacturing site in the United States. You will shape feasibility through detailed design, coordinate with US and Danish teams, and govern CAPEX through the project lifecycle.

Regular travel to the US is required, and you will onboard key contractors while embedding Genmab’s culture and quality mindset into the new facility.

Qualifications

• PhD, MSc, or equivalent degree in Biochemistry, Chemical Engineering, Biotechnology, or related discipline.
• 15+ years of experience in biologics manufacturing with monoclonal antibody expertise.
• Deep process knowledge across upstream, downstream, conjugation, and preferably antibody‑drug conjugates and drug product filling.
• Experience with large‑scale CAPEX projects > USD 100 million and site startups.
• Regulatory inspections experience (FDA, EMA, PMDA, or equivalent).

Responsibilities

• Lead development of the feasibility, concept design, basic design, and detailed design phases for the manufacturing facility.
• Serve as primary reviewer, and where relevant contributor, for facility design, utilities, process equipment, manufacturing IT/automation, and related engineering design elements.
• Support selection, onboarding, and governance of key contractors and external partners in the US.
• Drive recurring project governance meetings and support steering committee preparation, follow‑up, and decision tracking.
• Establish robust project documentation practices, including document hierarchy categorization, version discipline, and decision records.
• Act as the primary link between the SVP, the CAPEX Project Manager/Site Head, QA and enabling functions primarily at Genmab headquarters in Denmark.
• Ensure the SVP and CAPEX Project Manager/Site Head have a shared, current view of progress, risks, decisions for the CAPEX project and dependencies in relation to site establishment.
• Facilitate timely escalation and resolution of issues requiring executive alignment or cross‑functional input.
• Collaborate with the SVP, CAPEX Project Manager/Site Head, QA and enabling functions to establish the initial team at the US manufacturing site.
• Support development of local processes, procedures, and ways of working aligned with Genmab’s standards and future operational needs.
• Help embed Genmab’s culture, collaboration model, and quality mindset into the new site as the organization scales.

Skills

Leadership

Communication

Stakeholder management

Project management

Financial acumen

Education

PhD, MSc, or equivalent degree in Biochemistry, Chemical Engineering, Biotechnology, or related

Job description

Genmab, based in Denmark, seeks a Sr. Director, Engineering Design to lead the establishment of Genmab’s first internal manufacturing site in the United States. You will shape feasibility through detailed design, coordinate with US and Danish teams, and govern CAPEX through the project lifecycle.

Regular travel to the US is required, and you will onboard key contractors while embedding Genmab’s culture and quality mindset into the new facility.