Senior Associate, Labelling & Packaging

The Role

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

Requirements

• 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.

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.