Lead LIMS Specialist for Operations at ALK

Do you want to work for a company that makes a difference every day for people with allergy? Do you want to take lead in the digitalization of the QC Lab and help drive the development of LIMS within the operational area? Do you thrive in a team within an informal environment?

We are searching for a new LIMS specialist who can take lead in driving the development of LIMS within the operational area at site Hørsholm. You will join a team of LIMS Super Users who supports the daily business operations and participates in cross functional projects to optimize and expand our business. Working in ALK provides great opportunities for personal development, having influence and making a difference.

Responsibilities

Our LIMS team has the responsibility of supporting the daily business operations, while also driving the process for digitalization of our laboratory to create better and more compliant workflows. Furthermore, we contribute to defining and planning department strategies related to LIMS. Currently we are implementing a new version of SampleManager and this roll out will be the first of many important projects that you will be part of.

In This Position You Will Have The Opportunity To Have a Key Role In The Organization Both Globally And Cross-functional. Some Of Your Responsibilities Will Be:

• Responsible for the validated state of LIMS operational in Product Supply Hørsholm site.
• Responsible for the LIMS User Requirement Specification (URS).
• Owner of cross-functional business process procedures & instructions.
• Overview and coordination of changes and new implementations in LIMS and integration to SAP.
• Ensure prioritization and alignment across the organization on tasks and changes related to LIMS.
• Responsible for cGMP compliance of LIMS in operation, including the requirements related to Computerized System Validation.
• Develop and maintain LIMS systems to support operational excellence.
• Leadership on LIMS related improvement or maintenance projects.
• Develop and maintain overviews to provide a decision-making framework and status reporting for the management.
• Participate in defining and planning of department strategies in relation to LIMS on a tactical level for new and updated plans.

We work in a cGMP environment and according to the requirements of Computerized System Validation. Thus, all changes to LIMS are documented through change control processes, and various documents describing the procedures, requirements, test and validation plans, protocols, reports, etc.

Your Qualifications

• Bachelor’s degree or higher level within engineering, science, supply chain.
• Extensive knowledge and experience with LIMS, preferably with SampleManager or Labware.
• Knowledge/experience from GMP and pharmaceutical production, incl. change control cases.
• Project work experience, either from handling small to medium complex projects or from participation in projects.
• Strong collaboration and communication skills.
• Fluent in spoken and written Danish and English.

Personally, you are passionate about your assignments. You are open minded, have a positive attitude and thrive in an environment with many stakeholders throughout the company. You like to take lead and responsibility, work structured and with respect to deadlines. At the same time, you should be flexible and motivated working in a busy environment where priorities and deadlines can change with short notice.

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 open-minded approach and contributing to an inspiring and fun working environment together with our colleagues.

ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. 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 from time to time.

Apply

For further information about the position, please contact Senior Manager Morten Elkrog Pedersen, phone no. +45 61 91 32 38.

Apply by attaching your CV and a short letter of motivation, no later than 29 February 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.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. We are looking forward to hearing from you!