Scientist for analytical method development and validation in Late Stage Analytical Development

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Hørsholm

Are you early in your career and would you like to work in a dedicated team responsible for developing and validating analytical methods? Do you have experience with development of various analytical techniques such as HPLC, ELISA or iCIEF?

ALK is a global allergy solution company that offers a wide range of allergy treatments, products, and services to meet the needs of those who suffer from allergies, in search for a skilled Scientist for our Late Stage Analytical Development (LSAD) department. The department analyses products under development, develops, optimises, and validates analytical methods, transfers analyses to the commercial analytical area, and participates in CMC development projects. LSAD also supports the preparation of regulatory documents and contributes during inspections by authorities and partners. It is a department known for its high expertise, professionalism, pro-active and open-minded approach. If you are looking to have influence and make a difference, ALK is the right place to be. Come join us, as we are excited to meet you!

The position
As a Scientist in LSAD, you will be part of Analytical Development consisting of 40 committed colleagues divided into 4 departments and a core team. You will report directly to the Director of LSAD. The team consists of eight scientists and three laboratory technicians. All deliveries in LSAD are made with a high focus on quality and regulatory requirements. Organisationally, Analytical Development is part of Global CMC Development in R&D.

Your primary tasks will be to:

  • Develop and validate new relevant analytical methods to the appropriate GMP level for clinical phase I – III applying innovative approaches.
  • Prepare experimental plans and evaluate results in collaboration with laboratory technicians and scientists in the department.
  • Analyse and interpret complex data sets.
  • Prepare protocols and reports.
  • Contribute to the continuous improvement of data handling from laboratory experiments.
  • Prepare documentation for authorities.

Your profile
We expect that you:

  • Have an education as a Master of Science in Engineering, Master of Pharmacy, or similar – preferably with a relevant Ph.D.
  • Have experience with various analytical techniques such as HPLC, ELISA, SEC-H/UPLC or iCIEF, and other relevant bioanalytical methods.
  • Have an interest in developing and implementing quality control assays for biologics incl. applying DoE and innovative approaches in refining analytical methods and improving efficiency without compromising quality.
  • Have an interest in analysing and interpreting complex data sets, including the use of statistical software and tools e.g., JMP.
  • Have experience with GMP.
  • Good communication and collaboration skills, contributing to a culture of quality and continuous improvement.

As a person, you are team-oriented and positive, you critically address professional issues and balance between progress on tasks and the appropriate GMP level. You understand how to work in a structured and independent manner. You are result-oriented and have the will to take responsibility for the team’s and your own tasks.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 17 November 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

For further information regarding the position please contact Director Michala de Neergaard, +45 61911050.

We are looking forward to hearing from you!


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Hørsholm.

Jobbet er oprettet på vores service den 28.10.2024, 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
  • Hørsholm

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