CMC IT Systems administrator

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.

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

As our new IT system administrator you will provide administrative and developmental support to all of our QC IT systems in our brand-new GMP QC Laboratory at Genmab. The laboratory is responsible for supporting Genmabs innovative products by performing release and stability testing according to ICH guidelines. Systems are mainly the Labvantage Laboratory Information Management System (LIMS), the Laboratory Empower Chromatography Data System and additional software used to control analytical equipment.

A key part of this role is the administrating  of the live IT systems. The role requires a detailed understanding of the LIMS and Empower system used by QC and its maintenance requirements. The IT system administrator will own the system SOPs and WIs (work instructions) and associated training packages. The position requires compliance with regulatory requirements working to cGMP.

Responsibilities

• Responsible for practical aspects of maintaining the validated state of GxP systems.
• Liaison between System Users, Application Managers (IT) & QA.
• Drives Business related aspects of application design, testing, operations, and system improvements.
• Manage user access administration.
• Provide initial and on-going training for users.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Performs all aspects of QMS process’ – Change Control, Deviations, CAPAs, writes, reviews, assesses, and/or approves change controls for software used in QC lab.
• Report achievements and escalate issues.
• Load and configure method templates in LIMS and Empower.

Requirements

• 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.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 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 employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.