Scientist for Laboratory Automation Development

Are you a Scientist with a flair for IT systems and experience in qualifying analytical instruments — and are you ready to be part of a journey driving laboratory automation and digital transformation?

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 Laboratory Automation Development department. In this role, you will join a team of specialists committed to GMP qualification of laboratory equipment and software validation for our analytical laboratories. Also, you will be involved in cross-functional activities in collaboration with IT, QA and the analytical laboratories. The Laboratory Automation Development department is known for its high expertise, professionalism, pro-active and open-minded approach. If you’re ready to make an actual impact and be part of a team that’s shaping the future of laboratory operations at ALK, the Laboratory Automation Development department is the place to be. Join us — we’re in motion, and we’re excited to meet you!

The Position
As a Scientist in the Laboratory Automation Development department, you will be part of the Analytical Development area, which consists of 40 dedicated colleagues organized into four departments and a core team. You will report directly to the Associate Director of Laboratory Automation Development. 

The Laboratory Automation Development team currently includes six experienced specialists and is responsible for the scouting, implementation, qualification, and lifecycle management of analytical equipment and software systems running at ALK’s analytical laboratories. In addition, the team acts as system and data owners for key analytical platforms and their associated data and are responsible for driving the laboratory automation agenda within the CMC area. Organisationally, Analytical Development is part of Global CMC Development within the Research and Development area.

Responsibilities:

• Perform qualification of new analytical instruments and validation of computerized systems for both development and GMP laboratories.
• Prepare qualification and validation documentation including risk assessments, protocols, and reports.
• Ensure the validated and qualified state of laboratory systems is maintained throughout their lifecycle.
• Work in compliance with applicable regulations and guidelines, including 21 CFR Part 11/211, EU GMP Guide, Annex 11 and 15, and GAMP5 principles.
• Support audits and inspections by providing documentation and subject matter expertise.
• Collaborate cross-functionally with IT, QA, and laboratory stakeholders to ensure efficient implementation and operation of qualified systems.
• Contribute to the identification, evaluation, and implementation of new systems and technologies that support automation and digitalization of laboratory operations.

Your profile
We are looking for a Scientist who:

• Holds a Master's degree or a PhD in engineering, natural sciences, or a related field.
• Has solid experience in qualification and validation of analytical instruments and laboratory software, preferably in both development and GMP environments.
• Has a good understanding of laboratory digitalization and is motivated to support the introduction of new technologies that improve laboratory efficiency.
• Is driven by the opportunity to enhance and streamline processes and systems.
• Has experience within programming.
• Is adaptable, solution-oriented, and thrives in a dynamic environment.
• Has strong communication and collaboration skills, contributing to a culture of quality, innovation, and continuous improvement.

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 development of skills and knowledge. We will provide the necessary training for you to become a specialist in instrument validation and qualification. 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 1 June 2025.

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 Associate Director, Rune S. Gustafsson at +45 50899596.

We are looking forward to hearing from you!