Principal 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 within biologicals and small molecules?
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 is part of Global R&D, counting 49 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 13 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 encompassing biologicals (mAbs) and 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 complex scientific tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be responsible for scientific and project management tasks within the department´s responsibilities for analytical support of small molecule and biological (mAb) specification methods, technical transfer of analytical methods for local release testing or between LEO Pharma CMOs, 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 within small molecules and biologics. Analytical tasks within Leachable and Extractable studies is a responsibility lifted in close collaboration with scientists from other organisational areas.
As a part of your daily tasks you will be expected to:
The ideal candidate:
The ideal candidate has profound analytical experience within biologicals (mAbs) and small molecules, is a team player with strong collaboration skills, outgoing, tolerant and solution oriented. You have a can-do attitude and are responsible, flexible, and a competent decision-maker. You freely share knowledge to colleagues and thrive in being a go-to person for advice on analytical matters. You are fully familiar with working under GMP and in regulated environments and have the business perspective to weigh cost and risks in a pragmatic balance.
Your experience and competences:
Contact & application:
Do not hesitate to contact Senior Manager Birthe Ross +45 5365 4753 if you want to know more about the position. Deadline is January 3rd 2021. Job interviews will be held on a continuous basis. We look forward to receiving your application.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.
LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. Read more at leo-pharma.com
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 is part of Global R&D, counting 49 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 13 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 encompassing biologicals (mAbs) and 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 complex scientific tasks and work on several projects at the same time.
Primary areas of responsibility:
You will be responsible for scientific and project management tasks within the department´s responsibilities for analytical support of small molecule and biological (mAb) specification methods, technical transfer of analytical methods for local release testing or between LEO Pharma CMOs, 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 within small molecules and biologics. Analytical tasks within Leachable and Extractable studies is a responsibility lifted in close collaboration with scientists from other organisational areas.
As a part of your daily tasks you will be expected to:
- Prepare analytical validations and investigations
- Plan and execute analytical development, optimisation 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
- Conduct stability evaluation of marketed products
- Collaborate globally with external stakeholders, partners, CMOs and CROs
- Take on project management for e.g. coordination of analytical method transfer, complex OOS resolutions
- To some extent write and update quality documentation for regulatory purposes in connection to life cycle management activities, internal projects, questions from authorities, renewals and applications.
- Participate in global, cross-organisational improvement projects across LEO Pharma
- Provide decision scenarios and advise management groups on best way forward in analytical matters
- Coordinate and report on Leachable and Extractable studies in collaboration with scientists from other organizational areas
- Provide input for Justification of Specification and specification limits
The ideal candidate:
The ideal candidate has profound analytical experience within biologicals (mAbs) and small molecules, is a team player with strong collaboration skills, outgoing, tolerant and solution oriented. You have a can-do attitude and are responsible, flexible, and a competent decision-maker. You freely share knowledge to colleagues and thrive in being a go-to person for advice on analytical matters. You are fully familiar with working under GMP and in regulated environments and have the business perspective to weigh cost and risks in a pragmatic balance.
Your experience and competences:
- You hold a Ph.D. or similar experience within pharmaceutical sciences, chemical engineering or equivalent education
- Have solid and relevant experience from biopharmaceutical and preferably also small molecule pharmaceutical industry
- A minimum of 10 years of experience within analytical chemistry, specification setting and stability testing, strong end-to-end CMC understanding, including insight in development, validation and implementation of HPLC/UPLC methods and relevant statistical tools
- Experience with conducting Leachables and Extractables studies
- You have experience in working with Partners, CMOs/CROs and HA appointed local laboratories and have proven skills for creating a good collaboration atmosphere
- Experience with technical transfer of analytical methods
- Excellent stakeholder management skills and experience in working in multi-cultural project teams
- A solid experience with GMP as we work in regulated areas including experience with HA audits
- Good communication skills (English and Danish/Scandinavian)
- Experience with regulatory requirements, pharmacopoeias and authority guidelines
- Preferably LEAN experience or experience with continuous improvements
Contact & application:
Do not hesitate to contact Senior Manager Birthe Ross +45 5365 4753 if you want to know more about the position. Deadline is January 3rd 2021. Job interviews will be held on a continuous basis. We look forward to receiving your application.
About LEO Pharma
At LEO Pharma, we are pioneering together. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.
LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. Read more at leo-pharma.com
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 5.11.2020, 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
- Søndag den 03. januar 2021
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