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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
- Country DK - Denmark
- Job Location Ballerup
- Minimum Qualification Bachelor's
- Job Category Other
- Job Shift Day Shift
- Gender Requirement Male