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!
The Role and Team
Genmab is searching for an enthusiastic Senior Clinical Drug Supply Associate to be part of Global Clinical Drug Supply Operations in Copenhagen or Princeton within commute distance from our office locations to work according to your hybrid work arrangement.
Having an impressive pipeline and many ongoing clinical trials, you will have a central role in the execution of tasks related to packaging, labelling and distribution of clinical trial supplies for early as well as late-stage clinical trials, for patients with cancer and other serious diseases.
This is done in close collaboration with GMP QA colleagues and our CMOs ensuring timely execution. All manufacturing activities are outsourced, which is why you must be skilled in professional and clear written and oral communication to ensure activities are carried out as per expectation.
You must be an initiative driven and proactive player with responsibility to deliver high quality trial supplies on time from an operational perspective. Changes are a natural part of our work, so you are able prioritize your tasks and balance importance with urgency.
You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs.
Together with Global Clinical Drug Supply Systems team the three teams make up the Global Clinical Drug Supply department.
We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.
The position reports to the Associate Director, Team Lead, Global Clinical Drug Supply based in Princeton.
Responsibilities
- Creation and review related to setup of clinical labels from English Master Label to translation and proof reading.
- Order products via CMOs and sourcing vendors for use in clinical trials as per relevant legislation.
- Review and approve Master Batch Records generated by our CMOs to ensure compliance with cGMP.
- Maintain batch overview including batch release overview as per alignment with Global Clinical Drug Supply Planning and GMP QA.
- Evaluate temperature excursions reported by our CMOs and clinical sites.
- Perform batch reconciliation and oversee destruction of product at our CMOs.
- Stakeholder engagement and collaboration related to drug supply operations e.g., GMP QA and CMOs/vendors for packaging, labelling and distribution.
- Support trouble shooting and execution of risk mitigation plans.
- Train colleagues in Global Clinical Drug Supply Operations.
- Support inspection and audit preparation and execution.
- Participate in maintenance of SOPs.
- Responsible to be compliant with Genmab´s quality system.
Requirements
- Minimum a bachelor’s degree or equivalent.
- Advantage with 2+ years’ experience in handling clinical drug supply, including setting up label text, handling of ancillaries, distribution with cold chain management from CMO, Biotech or Pharma companies.
- Experience in working with CMO for clinical trial supplies.
- Knowledge and understanding of GMP, GDP, and GCP.
- Proven experience working in teams.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines.
- Ability to be proactive, enthusiastic, and goal orientated.
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support the execution of tasks.
- Strong communication skills in English - both oral and written.
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 you’re 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, Genmab’s 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 Genmab.com and follow us on LinkedIn and X.
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