Senior Analytical Scientist to Pharmaceutical Product Support
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Are you passionate about improving lives of millions of people by supporting LEO Pharma 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 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 (primarily 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 be responsible for scientific tasks with the department´s responsibilities for analytical support, technical transfer of analytical methods, 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:
prepare analytical validations and investigations plan and execute analytical development and support lead and participate in solution of different analytical- or production-related issues (e.g. OOS and OOT observations) by identification of root cause and implementation of corrective actions prepare analytical transfer documentation stability evaluation of marketed products project management e.g. coordination of analytical method transfer, OOS resolutions participate in global, cross-organisational projects across the LEO Pharma collaborate with external stakeholders, CMO´s and CRO´s globally to some extent write and update quality documentation for regulatory purposes in connection with maintenance activities, internal 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:
A minimum of 5 years of experience within analytical chemistry and stability testing, strong CMC understanding, including insight in development, validation and implementation of HPLC/UPLC methods and relevant statistical tools
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
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
A solid experience with GMP as we work in regulated areas
Good communication skills (English and Danish/Scandinavian)
Experience with regulatory requirements, pharmacopoeias and authority guidelines
Preferably LEAN experience or experience with continuous improvements
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 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 (primarily 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 be responsible for scientific tasks with the department´s responsibilities for analytical support, technical transfer of analytical methods, 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:
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:
A minimum of 5 years of experience within analytical chemistry and stability testing, strong CMC understanding, including insight in development, validation and implementation of HPLC/UPLC methods and relevant statistical tools
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
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
A solid experience with GMP as we work in regulated areas
Good communication skills (English and Danish/Scandinavian)
Experience with regulatory requirements, pharmacopoeias and authority guidelines
Preferably LEAN experience or experience with continuous improvements
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 4.6.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Ballerup
- Lørdag den 17. august 2019
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