Job SummaryAbout Us
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
Genmab is now searching for an experienced Late Stage CMC Project Manager (PM) to be a part of the CMC Operations team in Copenhagen.
As responsible CMC PM you will be generating and executing the overall CMC strategy and planning within selected projects from the Genmab portfolio.
The CMC PM will be part of the team of CMC PMs supported by specialists for e.g. assay/process validation, product characterisation and Fill&Finish.
The CMC department at Genmab currently employs 25 people and you will report to Associate Director, Team Lead, Late Stage Manufacturing CMC.Key Accountabilities
As responsible CMC PM you will have the following responsibilities but not limited to:
- CMC late stage development activities towards BLA/MAA
- Managing CMC activities at CMOs
- Responsible for the internal alignment in the CMC Management Team
- CMC representative in the Compound Development Team
- Authoring and reviewing regulatory CMC submissions
- Budget responsibility for the CMC Programs
- Supporting the maintenance of CMC Operations’ quality system
- You have a relevant master’s degree in natural or engineering sciences
- 5-10 years experience working with bio-pharmaceuticals within CMC and preferably with late stage development activities
- You have proven track record and the technical skills of biological process development and bio-pharmaceutical manufacturing
- Experience within CMC project management is required
- GMP understandig and understanding of CMC principles, industry practices within the field of expertise
- Fluency in English and preferably Danish/Scandinavian
Moreover, you meet the following personal requirements:
- You are a dedicated team player and an inspiring communicator with excellent social skills
- You are proactive and open minded
- You have a quality mindset and are able to prioritize your work in a fast paced and changing environment
- You are result- and goal-oriented and committed to contributing to the overall success of Genmab.
- Ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals
- An independent work-approach and good at building solid professional relations to collaborators and business partners
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 Jannie Jensen, firstname.lastname@example.org.
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To learn more about Genmab, you can visit our website: http://www.genmab.com/