Senior Associate, GMP Technician, Global Clinical Drug Supply

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

Genmab is looking for two dedicated Senior Associate GMP Technicians to join our new clinical secondary packaging and labelling facility in Ballerup which is currently under this role you will be part of a small agile team driving the rapid start-up of our clinical trials with a particular focus on first-in-human (FIH) and early-phase studies. You will help ensure that high-quality investigational medicinal products reach patients with cancer and other serious diseases on time and in full.

As Genmabs first in-house GMP production capability for secondary packaging and labelling this position offers a unique opportunity to help shape our ways of working from the very beginning. You will be responsible for secondary packaging labelling and related GMP activities in a small-scale manual set-up where your contribution will have a direct impact on timelines and quality.

The role combines hands-on production work with ownership of equipment maintenance documentation and continuous improvement across end-to-end production and facility-related processes.

The role is based at our Ballerup site and due to the nature of GMP operations requires on-site presence.

The position reports to the Associate Director Team Lead Global Clinical Drug Supply based in Ballerup.

Responsibilities

• Perform secondary packaging and labelling activities for clinical trials according to approved batch documentation and GMP including manual set-up and operation in-process checks and reconciliations and timely accurate completion of batch documentation and logbooks

• Carry out label set-up and printing using validated systems and templates ensuring labels are created and printed according to approved texts and design layouts

• Support the creation and maintenance of Master Batch Records and packaging instructions for secondary packaging and labelling activities by providing practical input

• Assist with equipment-related tasks in the packaging and labelling area such as operation cleaning and basic maintenance and support qualification calibration and validation activities under guidance

• Highlight and help troubleshoot equipment issues to support minimal downtime in a fast-paced environment

• Follow and contribute to SOPs work instructions and checklists and ensure all activities are performed in accordance with GMP GDP and Genmabs quality system including data integrity principles

• Support the handling of deviations change controls and CAPAs within your area by providing accurate operational details and participating in implementation of agreed actions

• Participate in preparations for audits and inspections by ensuring your own area is inspection-ready and documentation is up to date

• Perform inventory and material management for labels packaging materials and relevant consumables including receipt storage issuance reconciliation and stock checks

• Handle waste management from packaging and labelling operations including segregation documentation and disposal in line with SOPs safety and environmental requirements

• Contribute to the practical set-up of new clinical trials with focus on first-in-human and early-phase trials by following instructions being flexible and raising potential issues that may impact packaging timelines or product availability

• Participate in continuous improvement activities within the packaging and labelling area by sharing observations suggesting practical improvements and helping to implement agreed changes

Qualifications

• Vocational education within pharmaceutical production laboratory technology process technology or a similar technical field; a Bachelors degree in a relevant area is an advantage but not required

• 3 years of experience from a GMP-regulated environment (e.g. pharmaceutical production clinical packaging aseptic/solid dose manufacturing or similar)

• Hands-on technical mindset with the ability to operate equipment and learn basic maintenance under guidance and to quickly learn new systems and tools

• Experience with label printing systems cold storage equipment or clinical trial materials is an advantage but not a requirement

• Experience from a small-scale or start-up-like facility based on manual processes is considered a plus

• Basic understanding of GMP principles and documentation practices and willingness to develop further in this area with high attention to detail and quality

• Proficient in English (written and spoken); Danish is an advantage

• Good IT skills and willingness to learn and use new digital tools and systems

Who You Are

You are motivated by hands-on work in a GMP environment and keen to build your experience within clinical packaging and labelling. You are structured and reliable and you take responsibility for your own tasks seeking support and clarification when needed to ensure high quality and compliance. You enjoy working in a small collaborative team where flexibility and a practical mindset are important. You are curious and open to learning and you see it as exciting to join a greenfield setting where not everything is defined yet and where your input can help shape daily routines over time. You are comfortable in a dynamic fast-paced environment where priorities can change and you are willing to support critical timelines for clinical trials by being organised thorough and solution-oriented in your daily work.

The Team

You will join a team under establishment at our new packaging and labelling facility in Ballerup with the ambition to be recognized as a highly skilled and collaborative group. The team will work closely with colleagues in Global Clinical Drug Supply Manufacturing in Valby and Princeton as well as across Genmabs global geographies. Together you will be dedicated to ensuring timely high-quality packaging and labelling of clinical trial supplies and to continuously improving our processes in line with Genmabs ambition to transform the lives of patients with cancer and other serious diseases.

Application

If this opportunity excites you please upload your CV and a short cover letter explaining your motivation for the role. Applications are reviewed on an ongoing basis and interviews will be scheduled accordingly.

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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