Associate Director Tech Transfer Lead

Job description

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! At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose. The Role and Departmen t We are looking for an Associate Director, Technology Transfer Lead, to lead a team of Project Managers responsible for global process transfers in Genmab’s late-stage CMC organization. The scope covers biological intermediates (BI, e.g. monoclonal antibodies), chemical intermediates (CI), conjugated drug substance (DS) and drug product (DP). You will report to the Senior Director, Head of Late-Stage Manufacturing Development Project Management, within Genmab Tech Ops in Denmark. You will work across CMC teams and technical functions, Quality, Regulatory Affairs and Supply Chain to align transfers with program strategy and supply needs. You will combine people leadership with oversight of transfers across sites and contract development and manufacturing organizations (CDMOs). You will lead selected complex transfers, ensuring receiving-site readiness, documented handover and continuity of supply. Responsibilities Team leadership and development 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 Global process transfer responsibilities 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 escalate issues with clear options and recommendations. Protect supply continuity throughout the transfer CDMO collaboration and project governanc e 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 Requirements 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. About You You enjoy developing people and taking responsibility for delivery. You set clear priorities, delegate effectively and remain available as a coach and sparring partner. You bring structure to complex transfers and act early when risks or competing demands arise. You build constructive relationships with technical specialists and manufacturing partners, and challenge assumptions while maintaining trust. You connect decisions across the supply chain, exercise sound judgment and value a ONE-Team approach to delivering shared goals. Location and Travel The role is based in Denmark, with international travel to Genmab locations and external manufacturing partners. Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect our employees. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate. The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is: DKK624.000,00---936.000,00 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. When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to: Pension Health insurance and wellness benefits Paid time off Employee support programs Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process. 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