Senior Analytical Scientist to Support Marketed Biological Products

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Ballerup

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. 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

In our area we provide fast, efficient and qualified pharmaceutical documentation and analytical support for all marketed products at LEO Pharma. 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. On the biological portfolio we work together with external partners and CMOs.

You will be part of a team that will be responsible for the products encompassing biologicals (mAbs) and small molecules. Our values are Impact, Courage, Trust and mutual respect and helpfulness – and we care about each other. As we are a support area, the team 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 tasks within the department´s responsibilities for analytical support of biological (mAb) methods conducted at CMOs, transfer of analytical methods for local release testing between CMOs, set-up and evaluation of stability studies, OOS and OOT resolution, support during Health Authority inspections and to some extent life cycle management activities.

Examples of tasks are:

  • Conduct stability evaluation of marketed biological products
  • Take leading role for coordinating and facilitating analytical method transfers and complex Out of Specification resolutions
  • Test, optimise and validate analytical methods for marketed products
  • Collaborate globally with external stakeholders, partners, CMOs and CROs
  • Participate in cross-organisational improvement projects across LEO Pharma
  • Provide decision scenarios and advise management groups on best way forward in analytical matters
  • Provide input for Justification of Specification and specification limits
  • Be involved with the establishment of new processes in working with CMOs

Your qualifications:

You have a profound analytical experience and passion within biologicals and mAbs. You are a team player with strong collaboration skills, outgoing, tolerant and solution oriented. You have a can-do attitude and are responsible and flexible as well as 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 familiar with working under GMP for marketed products and in regulated environments and you have the business perspective to weigh cost and risks in a pragmatic manner.

Your background:

  • You hold a Master Degree within pharmaceutical sciences, chemical engineering, biochemistry or equivalent education and have solid and relevant experience from biopharmaceutical industry
  • A minimum of six years of hands-on experience within analytical chemistry and mAbs, Specification setting and stability testing
  • Experience in working with CMOs and contract laboratories
  • Hands on experience with technical transfer of analytical methods
  • Strong ´development-to-market´ CMC understanding, including insight in analytical method development, validation and implementation
  • Solid experience with GMP including Health Authority inspections
  • Excellent communication skills (English and Danish/Scandinavian)
  • LEAN experience or experience working with continuous improvements is considered an advantage

Further information

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 April 22nd 2021.

Location:

Ballerup

Job type:

Permanent

Working hours:

Full-time

Working days:

Day


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 1.4.2021, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Forsker
  • Ballerup
  • Torsdag den 22. april 2021
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