The Role
In this newly created role, the Sr. Director, Engineering Design will play a critical leadership role in evaluating options and then establishing Genmab’s first internal manufacturing site in the United States, ensuring that engineering design, CAPEX execution readiness, and site establishment are advanced with clarity, pace, and strong governance.
Based in Denmark and reporting to the SVP, CMC Development and Manufacturing, the role will drive development of the feasibility, concept design, basic design, and detailed design phases for the new manufacturing facility in close collaboration with external partners and Genmab colleagues in both Denmark and the US.
The role will serve as a key integrator between the CAPEX Project Manager/Site Head based in the US, the SVP based in DK, QA and enabling functions primarily at Genmab headquarters in Denmark, ensuring aligned decision‑making, clear escalation, and shared visibility of progress for the CAPEX project and alignment with site establishment activities.
In addition, the role will support the selection and onboarding of key contractors and partners, contribute to establishing the initial US manufacturing site team, and help translate Genmab’s operating model and culture into the new manufacturing environment.
Regular travel to the US will be required.
Key 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.
Required Qualifications
Education
- PhD, MSc, or equivalent degree in Biochemistry, Chemical Engineering, Biotechnology, or a related discipline.
Experience
- 15+ years of experience in biologics manufacturing within the biotech or pharmaceutical industry, including strong technical expertise in monoclonal antibody manufacturing.
- Deep process knowledge at thought‑leadership level, including upstream, downstream, conjugation, and preferably antibody‑drug conjugates and drug product filling.
- Strong understanding of manufacturing IT/automation, utilities incl. HVAC, process equipment, and site infrastructure.
- Proven experience with large‑scale CAPEX projects of more than USD 100 million, site start‑ups, and/or facility expansions, including establishing and managing user requirements.
- People leadership experience in commercial biologics manufacturing operations.
- Experience with validation concepts and process qualifications.
- Experience with regulatory inspections, including FDA, EMA, PMDA, or equivalent authorities.
Competencies
- Excellent project leadership skills with a proven ability to establish effective collaboration with external partners.
- Strong financial acumen and ability to support disciplined CAPEX decision‑making.
- Strong stakeholder management and cross‑functional collaboration capabilities.
- Excellent communication skills and ability to navigate across all organizational levels.
Salary
The proposed gross annual/base salary range for this position, in the primary location, based on a full‑time schedule is:
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The final salary offer will depend on several factors, including your skills, qualifications, and experience.
In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long‑term incentives.
Benefits
- Pension
- Health insurance and wellness benefits
- Paid time off
- Employee support programs