Associate Director, Global Tech Transfer Lead

Genmab; København; Hybrid; DKK 624,000 - 936,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is seeking an Associate Director, Technology Transfer Lead, to head a team of Project Managers responsible for global process transfers in our late-stage CMC organization. You will partner with Quality, Regulatory Affairs and Supply Chain to ensure smooth transfers across BI, CI, DS and DP.

The role combines people leadership with hands-on oversight of CDMO collaborations, with a focus on readiness, documentation and continuity of supply.

Qualifications

• Master’s degree or higher in natural sciences, pharmacy, engineering or a related discipline.
• Extensive CMC experience in the pharmaceutical or biotechnology industry, including technology transfer and late-stage development or commercial manufacturing of biologics
• Demonstrated experience leading complex transfers between manufacturing sites and CDMOs, including integrated planning, budget management, risk management and coordination across regions
• Sound understanding of antibody manufacturing and the interfaces between BI, CI, conjugation and DP.
• Experience with antibody-drug conjugate (ADC) technology transfers is an advantage
• Practical understanding of process and analytical transfer, comparability, process validation, manufacturing readiness and the associated CMC submission requirements
• Working knowledge of GMP and global CMC regulatory expectations, and experience managing CDMO relationships and project governance.
• Excellent written and verbal communication skills in English, with the ability to explain complex issues, present recommendations and collaborate across functions and cultures.

Responsibilities

• Lead and develop a team of Project Managers, including resource planning, recruitment, performance management and professional development
• Coach team members in transfer leadership, stakeholder management and resolving issues across sites. Set clear expectations and encourage open dialogue and shared accountability
• Work with the Senior Director to align team priorities and resources with the transfer portfolio, address capacity constraints and strengthen collaboration across the project organization
• Translate transfer strategies into integrated plans with clear scope, ownership, milestones, budgets and dependencies across BI, CI, DS and DP
• Lead planning with sending and receiving sites, coordinating gap assessments, process and analytical knowledge transfer, and readiness of facilities, equipment, materials and documentation
• Coordinate engineering and GMP campaigns, comparability, process validation and regulatory activities with functional leads. Establish transfer acceptance criteria and ensure documented handover to routine manufacturing
• Maintain current plans and risk assessments, manage dependencies between transfer streams, and elevate issues with clear options and recommendations. Protect supply continuity throughout the transfer
• Represent transfer programs in internal governance forums and relevant joint project and steering committees with CDMOs, within agreed responsibilities and decision authority
• Follow up on CDMO scope, deliverables, timelines and budgets with technical leads, Quality, External Manufacturing and Procurement. Prepare governance decisions and ensure agreed actions have clear owners and follow-up.
• Strengthen consistent transfer planning and readiness reviews, share lessons learned, and improve the Project Manual and tools. Support compliance with applicable quality processes in collaboration with Quality and functional experts

Skills

Team leadership

Resource planning

Recruitment

Performance management

Professional development

Transfer leadership

Stakeholder management

Cross-site collaboration

Project governance

CDMO coordination

Education

Master’s degree or higher in natural sciences, pharmacy, engineering or a related discipline

Job description

Genmab is seeking an Associate Director, Technology Transfer Lead, to head a team of Project Managers responsible for global process transfers in our late-stage CMC organization. You will partner with Quality, Regulatory Affairs and Supply Chain to ensure smooth transfers across BI, CI, DS and DP.

The role combines people leadership with hands-on oversight of CDMO collaborations, with a focus on readiness, documentation and continuity of supply.