Product Manager, CMC

The Role

As a CMC Supply Chain Product Manager, 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 Sr. Director Commercial Supply Chain.

You will work in a cross-functional team of experts accountable for the integrated product strategy and delivery of product in addition to lifecycle management activities for one or more assets/products. The Product Manager liaise  with Genmab Product partners, CMO’s, CMC SME’s and internal key stakeholders across the global organization (RA/MA/QA/Finance) to provide strategic oversight and ensure operational excellence for the lifecycle management after commercial launch.

The Product Manager acts as CMC lead for the product in close consultation with functional leads, has responsibility over the entire product (including ensuring drug for clinical studies), works within the team governance framework, and is responsible for regular updates to governance.

This is a newly created role within Genmab CMC and truly exciting opportunity for to lead and drive all aspects of the lifecycle management of a compound. 

Key responsibilities include

• Work closely to influence, advise, and coordinate strategic and operational efforts across all key product development functions, including Development, Regulatory, Safety, CMC, Medical Affairs, Finance and Commercial, to ensure strategic alignment and seamless execution

• Interact with Supply chain CMO’s and Genmab Product Partners to keep track of lifecycle activities and coordinate implementations with internal stakeholders. Including facilitation of CMC processes for Product Management. Eg. process performance verification (CPV), Product costing etc.

• Flex between high level strategic views and delving into details at a (scientific, medical, development), CMC and commercial level as needed in partnership with the teams. Maintain strong industry awareness to ensure that product lifecycle plans reflect current scientific/medical developments and regulatory/commercial environment

• Be objective and create solutions to address complex cross-functional problems, be accountable for obtaining stakeholder advice to make informed, data-driven decisions, taking smart and calculated risks to move a program forward in a highly complex, uncertain, and competitive environment

• Build a high performing product management network culture by engaging matrix team members on the vision and ensuring clear team member roles and responsibilities, promoting team cohesiveness to optimize performance, ensure accountability of team members, and mediate conflict resolution

• Drive decision-making, lead discussions and challenge functional representatives when needed to ensure that all issues and questions are being addressed, and that functional area input into the strategy is adequate to meet the needs of the compound

• Work with Quality Assurance in order to maintain GxP compliance throughout the Product supply chain network and life cycle. This includes quality events handling – support investigations of  quality events, determine root causes, implement CAPAs and drive closure

Requirements

• Master in related field from either University or Technical University (Master preferred)

• At least 10 years of bio-pharmaceutical industry experience

• Experience in product lifecycle management is required

• Experience working with corporate partners and alliance management

• Cross Functional Project Management experience

• Strong interpersonal skills, solid communication skills and excellent teamplayer

• Good at multi-tasking and able to deal with high pressure situations

• Proven ability to function effectively across a global matrix organization with multiple stakeholders, with the ability and strength to focus a team to work towards its goals

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.