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 Department
Our QC lab is growing in activities and looking to recruit a IT System Administrator to join our team onsite in Ballerup.
As IT system administrator at Genmab, you will provide administrative and developmental support to all of our QC IT systems in our Quality Control Laboratory. The laboratory is responsible for supporting Genmab’s innovative products by performing release and stability testing according to ICH guidelines. Systems are mainly the Labvantage Laboratory Information Management System (LIMS), but also the Empower Chromatography software and additional software controlling analytical equipment.
The role requires a detailed understanding of the LIMS and Empower systems used by QC and its maintenance requirements. The IT system administrator will own the system validation packages, the SOPs, and associated training packages.
The position requires compliance with regulatory requirements to cGMP. Unique to this position is the chance to define the way we work with laboratory IT systems at Genmab.
You will be joining a small team of ambitious and professional colleagues within related fields, who can help you settle into your role, and keep the spirit high while performing the important tasks for our laboratory. The laboratory is newly established, so expect a pioneering atmosphere, where you will help adjust the ways of working in an efficiency oriented direction. We expect you to be ambitious, motivated, self-driven, and to be able to make your colleagues shine in an environment of respectful and flexible collaboration.
You will report to Team Lead, QC systems.
Responsibilities
- Liaison between System Users, Application Managers (IT) & QA.
- Drives Business related aspects of system application operations, design, testing, and improvements.
- Manage user access administration and providing initial and on-going training for users.
- Responsible for practical aspects of maintaining the validated state of GxP systems.
- Ensure data integrity and compliance with company SOPs, requirement specifications, and cGMP regulations.
- Load and configure method templates in LIMS and Empower.
- Perform all aspects of QMS processes – Change Control, Deviations, CAPAs – for software used in QC lab.
- Report achievements and escalate issues.
Requirements
- It is expected that you have at least 5 years of documented professional experience working according to GMP in a QC setting
- You have a thorough understanding of the detailed requirements for Software Validation and are up to date with current trends
- Experience with qualification of analytical instruments is desirable as you will be the owner of the validation and qualification activities
- Experience in leading projects and driving cross-functional initiatives/stakeholders
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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