Associate Project Manager, Pharmaceutical Development, CMC

Genmab A/S

Vikariat
Storkøbenhavn

Associate Project Manager, Pharmaceutical Development, CMC

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 you will be based within the CMC Operations team at Genmab’s Copenhagen site. You will be responsible for various outsourcing activities with CMO’s for sterile fill operations and pharmaceutical/formulation developmen of multiple of Genmab’s antibody based products. You will perform your work in close collaborate with the overall CMC PM/Lead and you will be part of the CMC management team governing CMC programs throughout their lifecycle. You will meet regularly with CMO’s and collaborators. In additional you will be responsible for supporting CMC Operations maintenance and documentation review

Responsibilities

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

  • Oversight of Fill & Finish CMO’s and other collaborators
  • Managing and coordinating activities relating to sterile fill with CMO’s for Genmab project(s)
  • Together with CMC PM Lead set Fill & Finish strategy for Genmab project(s)
  • Pharmaceutical/formulation development for Genmab CMC projects
  • Authoring and reviewing regulatory CMC submissions.
  • Supporting the maintenance of CMC Operations’ quality system

Requirements

  • 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 sterile fill and/or development of the bio-pharmaceutical 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.

Moreover, you meet the following personal requirements:

  • The ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals.
  • Attention to detail 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.

In case you have any questions feel free to reach out to Recruiter Jannie Jensen at jjn@genmab.com

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.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a temporary employment agreement and a contract for indefinite time after two years of employment regardless of seniority.


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