Senior Specialist, Transport Validations

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!

The Role & Department

At Genmab we are committed to improving the lives of patients through innovative antibody therapeutics. As Senior Specialist Transportation Validation you will play a key role in ensuring that our products are transported safely compliantly and efficiently across the global supply chain.

You will be responsible for qualification and validation of transport solutions routes and equipment while driving continuous improvement and ensuring adherence to GxP and regulatory requirements. The role requires strong cross-functional collaboration and a proactive quality-driven mindset.

This will be part of an expanding team in Copenhagen and reports to Associate Director Head of Commercial Supply Chain.

Responsibilities

Transportation Validation & Qualification

• Lead qualification of shipping solutions and transportation equipment (e.g. thermal shippers containers temperature monitoring devices) in collaboration with CMC Logistics QA and RA

• Drive validation of shipping lanes for intermediates and finished goods across Genmabs global commercial network

• Ensure transportation solutions meet defined product requirements and regulatory standards

Equipment Qualification

• Plan and execute qualification activities for transportation equipment including thermal packaging systems and monitoring devices

• Ensure equipment performance is robust and documented in accordance with GxP expectations

Processes & SOP Ownership

• Develop maintain and continuously improve SOPs and related documents governing transportation validation and distribution activities

• Standardize and optimize validation processes to ensure scalability efficiency and compliance

• Ensure alignment with Genmabs Quality Management System

Risk Management & Documentation

• Maintain Product Risk Management Plans related to distribution.

• Lead Lane Risk Assessments to proactively identify and mitigate supply chain risks

• Author review and approve validation documentation (e.g. URS protocols reports) in line with internal and regulatory requirements

Vendor & Stakeholder Collaboration

• Support selection qualification and performance evaluation of transport solutions lanes and logistics service providers

• Collaborate closely with CMOs and external logistics partners to ensure compliant and effective distribution solutions

Quality & Compliance

• Partner with QA to ensure GxP compliance across the distribution network

• Lead investigations of deviations and transport-related exceptions including root cause analysis and CAPA implementation

• Drive timely closure of quality events and ensure continuous improvement

Requirements

• Bachelors or Masters degree in Life Sciences Engineering Supply Chain or related field

• Solid over 5 years experience in transportation validation cold chain logistics or pharmaceutical distribution

• Strong knowledge of GxP and global regulatory requirements for distribution

• Experience with equipment qualification and validation lifecycle (URS IQ/OQ/PQ)

• Experience working with CMOs and logistics service providers in a global setup

Competencies

• Patient-focused mindset with strong commitment to quality and compliance

• Collaborative approach able to work effectively across functions and with external partners

• Ownership & accountability with the ability to drive tasks independently to completion

• Analytical thinking and structured problem-solving skills

• Clear communication and stakeholder management skills in a global environment

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.

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