Associate CMC Project Manager
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The Role
As an Associate CMC Project Manager based in Copenhagen with the CMC team, you will support Genmab across various outsourcing activities with CMO’s for stability testing and sterile fill operations. In addition, you will support the CMC PM in aligning activities with project collaborators and outsourcing partners.
You will meet regularly with CMO’s and collaborators and be responsible for supporting CMC operation maintenance and documentation review.Key Accountabilities
The responsibilities of the Associate CMC Project Manager will include, but not be limited to:
- Supporting the CMC PM in alignment of pharmaceutical development activities for given projects
- Supporting the CMC PM in aligning and coordinate activities, documents and follow ups with CMOs and collaborators
- Managing and coordinating activities relating to stability testing internally and with CMO’s for given project(s)
- Managing and coordinating activities relating to sterile fill with CMO’s for given project(s).
- Participating in and organizing meetings with CMO’s and other collaborators regarding the oversite of external contacts.
- Supporting the maintenance of CMC Operations’ quality system and authoring and reviewing regulatory CMC submissions.
- Traveling to other sites up to 10-15 travel days per year.
- You have a relevant academic background and preferably a MSc qualification in a relevant natural science subject.
- You have a background working with biopharmaceuticals and experience in one of the fields of stability testing, sterile fill and/or development of the biopharmaceutical manufacturing processes.
- You have at least 3-5 years of experience within the biotech or pharmaceutical industry.
- You have experience of GMP and an understanding of CMC principles, industry practices and standards.
- A good understanding of quality systems and regulatory expectations.
- Fluency in English and preferably Danish/Scandinavian.
- The ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals.
- Attention to detail skills with expertise in documentation and coordination practices.
- An independent work-approach and good at building solid professional relations with collaborators and business partners.
- The ability to work in a fast-moving work environment.
- Able to work independently and as part of a team.
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.
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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Uthen Khamproh (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/