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API Coordinator - Principal/Senior Scientist , Ballerup

Created 12/21/2021
Reference 1717771893
Category Pharmaceutical
Job type Full Time
Country Denmark
City Ballerup
Zip Not specified
Salary Competitive
Do you want to drive and impact our development projects with your expertise within drug substance?

If you have a broad knowledge of process development and manufacturing of biological drug substances and at the same time like to coordinate activities and you are looking for a place, where your efforts will make a clear difference, this is it. At least, if you want to being part of a very informal and non-hierarchical environment in a company that experiences the most exciting period of development ever.

To fulfil our goal of becoming the world's preferred dermatology care partner we - among others - have embarked on a new journey with focus on building a biologic pipeline. When joining Biopharmaceutical Process Development as our coordination expert number one, you will make your mark on turning this into new successes.

Make the work of three teams and external partners come together

You will join a department of approximately 8 Scientists and Technicians. The department is responsible for all drug substance (DS) bioprocess activities throughout the full development value chain for monoclonal antibodies, including cell line selection and development, process development and productions.

Your job is to coordinate Upstream and Downstream activities from clinical to late-stage projects for our ongoing projects in close contact with our SME's and other departments in the Biopharmaceutical area. You will:
  • Coordinate process development and manufacturing activities through the different clinical development stages
  • Manage outsourced biologic activities to CROs/CMOs including selection of and contractual aspects
  • Compile and/or review relevant project documents, regulatory and quality documentation
  • Coordinate project activities with a range of internal stakeholders
  • Manage our overall project plan, report and present results to the CMC team
  • Manage project budget
  • Coordinate transfer of biological pre-clinical projects to clinical Development
  • Coordinate thetransfer of biological drug substance processes to MSAT/GPS organization responsible for commercial manufacturing
  • Be responsible for observing that all relevant regulations and guidelines are adapted and followed

Your new workplace is LEO Pharma's HQ in Ballerup Copenhagen.

Natural science degree backed by solid Drug Substance and coordination experience

Your background in the pharma industry has provided you with a toolbox of how to coordinate and drive activities in a natural science environment with people from different professional and cultural backgrounds. In our world "one size fits all" does not exist, you must be able to tailor your communication to your audience. You must also bring excellent overview and a very structured way of working.. Additionally, your CV comprises:
  • Minimum M.Sc. in pharmaceutical sciences
  • 5+ years' experience in the pharma industry including 3 years' experience in DS development
  • Experience with project coordination/management of both internal and external stakeholders
  • Team player
  • Motivation for working within GXP
  • Very good English skills, written and spoken

About Biopharmaceutical Development

The Biopharmaceutical CMC Development is a function consisting of 32 skilled employees spanning PhD level senior scientists and technicians working in our labs. We have established state of the art internal laboratories and capabilities and the work in the Biopharmaceutical Process Development department is constituted by a mix of work performed at CDMOs and internal process development activities. Our environment is characterized by collaboration, knowledge sharing and we strive to have a high scientific knowledge and a pleasant working environment

Contact and application

If you have questions, please do not hesitate to contact Kirsten Bisgaard-Frantzen, Senior Manager Biopharmaceutical Process Development, +45 25212788, KQBDK@leo-pharma.com .Please apply via the link at our website and remember to attach application and CV. The deadline is 31.01.2022. We look forward to receiving your application.

About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 6,000 people worldwide. For more information, visit www.leo-pharma.com.