The Role& Department
As a Senior Associate, Labelling & Packaging, you will be working in the CMC –Commercial Supply Chain. You will join a Supply chain function of currently 12 members and be reporting to Senior Director, Commercial Supply Chain.
The role will support the commercial supply chain activities as well as in the CMC department with focus on secondary packaging of new products at our CMO’s. Besides the product implementation activities the role will support building up a GxP compliant commercial manufacturing operations infrastructure in terms of systems and processes in corporation with our Contract Manufacturer(s) and QA. Hereunder routines for life cycle management and change and deviation handling.
Key responsibilities include
Support establishment of GMP compliant commercial packaging operation at Contract manufacturer(s) for Genmab key markets. Establish processes, procedures and systems procedures for product implemnation and commercial operation
Support Label and Pack Project Manager in the manufacturing activities; which encompasses: order preparation, manufacturing, batch review and release in corporation with QA
Support new product implemations at Label and Pack CMO by assisting Commercial product launch activities, support process validation activities within CMC and hereby making sure commercial launch supplies are available in global markets
Work with key business partners to develop launch and validation strategies with guidance from Labelling and Pack Project Manager
Work with Quality Assurance in order to maintain GxP compliance throughout the supply chain network including exceptions handling – Investigate exceptions, determine root causes, implement CAPAs and drive closure
Bachelor/Master in Engineering related education from either technical university or business school is required
A minimum of 5-8 years working experience is required
You hold technical experience and an engineering background preferably within the Biotech/Pharmaceutical industry or other regulated industries such Food/Medical device
You have experience within external manufacturing and GXP controlled environment
This role is located in Copenhagen and is hybrid.
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.