Project Manager/Analytical Coordinator with tech transfer experience
Are you passionate about improving lives of millions of people by supporting all our marketed products?This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. Global Research and Development in LEO Pharma devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. You can look forward to becoming part of a team with high professional standards in an informal atmosphere where tasks vary, and no days are alike.
Great opportunity within project management, analytical support and stability
Pharmaceutical Product Support Area is part of Global R&D, counting 40 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical documentation and analytical support for all marketed products at LEO Pharma.
You will join 12 enthusiastic and dedicated colleagues in the CMC Stability Support department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products, and we provide support for stability studies, analytical and chemical trouble shooting, technical transfer of analytical methods and documentation. You will be part of a product group and will be responsible for a minor portfolio of products (primary small molecules), together with scientists from the CMC MA Support department. Our values are impact, courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives a large number of unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.
Primary areas of responsibility:You will have a combined responsibility as project manager for various smaller and larger projects supporting CMC aspects of either Enstilar(R) manufacturing, or integration activities for our newly acquired Bayer dermatology portfolio along with scientific tasks within the department´s responsibilities for technical transfer of analytical methods, analytical support, set-up and evaluation of stability studies, OOS and OOT resolution, support during Health Authorities inspections and to some extent life cycle management activities and maintenance of regulatory documentation.
As a part of your daily tasks you will be expected to perform:
- project management e.g. coordination of analytical method transfer, OOS resolutions
- analytical transfer documentation
- manage and participate in projects across the LEO organization globally
- stability evaluation of marketed products
- collaborate with CMO´s and CRO´s globally
- leading and participating in solving different analytical or production issues by identifying root cause and implement corrective actions on OOS and OOT so the production can continue to release products to the markets.
- to plan and execute analytical development and support
- to prepare analytical validations and investigations
- leading improvement projects and cross functional projects
- to some extent - write and update quality documentation for regulatory purposes in connection with maintenance, projects, questions from authorities, renewals and applications.
The ideal candidate:The ideal candidate is a team player with strong collaboration skills, outgoing, tolerant and open-minded. You have a can-do attitude and are responsible, flexible, and a competent decision-maker.
Your experience and competences:
- Minimum of 2 years’ experience as project manager/analytical coordinator, including experience with technical transfer of analytical methods
- Excellent stakeholder management skills and experience in working in multi-cultural project teams
- You have experience working with CMO´s/CRO´s and have the competencies to create a good collaboration
- Master of Science in e.g. Pharmacy, Engineering or Chemistry and preferably in combination with a PhD. You are capable of analyzing and reducing complex issues and you are a person who thrives in significantly improving, changing or adapting existing processes, systems or products
- Minimum of 5 years of experience within analytical chemistry and stability testing, strong CMC understanding, including insight in development, validation and implementation of HPLC methods and relevant statistical tools
- Good communication skills (English and Danish/Scandinavian)
- A solid experience with GMP will be considered an advantage as we work in accordance with current GMP regulations
- Experience with regulatory requirements, pharmacopoeias and guidelines
- Preferably LEAN experience or experience with continuous improvements
Further informationPlease be aware that due to the collaboration with CMO´s, CRO`s and other LEO production sites up to 4 weeks per year of travelling can be expected.
Do not hesitate to contact Senior Manager Birthe Ross, +45 5365 4753 if you want to know more about the position.
We look forward to receiving your application. Deadline is 10 July 2019.
Job interviews will be held on a continuous basis.
- Region Hovedstaden
- Region Sjælland