CMC Project Manager

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

The Role

Genmab is now searching for a Project Manager to join the Late Stage Manufacturing Development (LSMD) Team of CMC Operations in Copenhagen. The LSMD team is responsible for the late stage development activities of Genmab’s portfolio projects and preparation of the CMC package for regulatory filings.

As CMC Project Manager, you will support the CMC Lead of one of Genmab’s late stage development programs, and you will be responsible for the coordination and planning of activities performed at our partnered CMO’s. In doing so, you will work closely with SMEs for e.g. upstream/downstream processing, analytical validation and characterization. Furthermore, you will ensure that Genmab’s products going through the late stage development activities will be performed according to latest industry standards and regulatory guidance.

The LSMD team at Genmab is currently employing 19 people, and you will report to the Senior Director, Head of Late Stage Manufacturing Development, CMC Operations.

Responsibilities

The responsibilities of the CMC Project Manager will include, but not be limited to:

• Responsible for the day-to-day CMC activities at our partnered CMO’s

• Support the CMC Lead for strategy and execution of CMC development towards BLA/MAA

• Support authoring and reviewing of regulatory CMC submissions (BLA, MAA, JNDA)

• Support and follow up on CMO and internal quality events as e.g. changes or deviations

• Support the maintenance of CMC Operations’ quality system

Requirements

• You hold as a minimum a Master´s degree in relevant natural sciences

• At least 4-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development

• You have a proven track record and the technical skills of biological process development/biopharmaceutical manufacturing

• Experience within CMC project management is required

• As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture, experience in running projects with external partners is preferred

• You have experience with the CMC technical sections of regulatory submissions, and interacting with global regulatory authorities

• Excellent communication skills in English, written and oral

Moreover, you should be able to meet the following personal requirements:

• Ability to work successfully under pressure in a fast-paced environment and with tight timelines

• You possess the ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals and team goals

• Be a team player with the ability to collaborate with a diverse group of internal and external stakeholders

• You are result- and goal-oriented and committed to contributing to the overall success of Genmab

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability or genetic information.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website: http://www.genmab.com/privacy/applicants-hr-genmab-a-s/

Scam alert

Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation.  This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.