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Do you want to be part of developing tomorrow's advanced therapies?

The Advanced Therapy Medicinal Products (ATMP) Centre at Skånes University Hospital in Lund is growing. We are now looking for a GMP Operator who wants to contribute to building and operating our modern GMP infrastructure for the manufacturing of advanced medicines.

The ATMP Centre is a new initiative within Region Skåne to enable the production of advanced therapies such as gene therapy, cell therapy, and tissue-engineered products within the hospital walls. We work in close collaboration with researchers, clinicians, and pharmaceutical developers to facilitate clinical trials and future treatments. We are currently in a setup phase and are looking for you who want to be part of this exciting journey.

The Centre is tasked with manufacturing, preparing, and coordinating clinical trials with ATMPs, as well as supporting academia and companies in the region who wish to conduct clinical trials with this type of medicine.

Region Skåne has a newly built GMP facility at Skånes University Hospital in Lund, which belongs to the ATMP Centre. The GMP facility contains cleanrooms for the manufacturing/preparation of ATMPs. The validation of the premises has been completed, and the first production of cell-based medicines is now being prepared. The ATMP Centre will also be part of the hospital pharmacy function and will prepare both market-approved ATMPs and investigational medicinal products.

1 position(s).

Job Description

As a GMP Operator, you will work with the manufacturing of cell-based medicines for clinical trials. You will also work in our laboratory with quality control. You will become part of an engaged team where quality, traceability, and patient safety are at the center. The work involves both practical laboratory/cleanroom work and extensive documentation according to GMP.

Your main responsibilities include:

• Aseptic work in B- and C-classified cleanrooms, for example, cell culture, harvesting, and formulation of cell-based medicines.
• Handling of GMO/GMM belonging to risk class I and II.
• Documenting manufacturing steps according to established procedures (batch documentation, deviations, logs).
• Working according to GMP and contributing to compliance with regulatory requirements, including improving procedures, risk analyses, and CAPA processes.
• Performing risk assessments and quality reviews of the production process and participating in the qualification and validation of equipment and facilities.
• Laboratory analyses with quality controls, for example, using cell counting, flow cytometry, and PCR.
• Ensuring that documentation, such as instructions, protocols, and reports, is up-to-date, correct, and in line with current guidelines.
• Development of new manufacturing processes and quality controls together with the preGMP unit at Lund University.

In your work with us, you will need to take significant responsibility as this is a facility under construction/setup. You will receive a developing and stimulating work environment as well as training adapted to the operations. Finally, you will join a positive group with high competence and visionary leadership.

Qualifications

We are looking for you who have education in one of the following areas: pharmacy, biomedicine, cell and molecular biology, biotechnology, or medical biology. You have very good knowledge of both Swedish and English, both spoken and written. We would appreciate if you have specific knowledge of induced pluripotent stem cells and/or tumor-infiltrating lymphocytes.

You have experience with GMP or other accredited operations, such as laboratory diagnostics or advanced research with high quality standards.

It is important that you are flexible, have very good teamwork skills, and are willing to help out where needed. You should be able to take initiative and perform your work independently. We value that you are quality-conscious, meticulous, have good teamwork skills, and are unpretentious. We place great emphasis on personal suitability.

We plan to have interviews at the end of week 24.

We warmly welcome your application!

Employment type: Permanent position.

Region Skåne is responsible for healthcare, public transport, and sustainable development throughout Skåne. Our highest decision-making body is the Regional Assembly, which is directly elected by the inhabitants of Skåne. Region Skåne is a values-driven organization that works with the values welcoming, driving, caring, and respect in everything we do.

Skånes University Hospital (Sus) is located in Lund and Malmö and is the country's third-largest hospital. Sus is a knowledge hub for healthcare at all stages of life on a regional, national, and international level. Our 12,000 employees are driving development within the university hospital's three mission areas: care, research, and education. With us, you will work in a values-driven organization that develops healthcare together with patients and their relatives. Welcome!

At https://www.skane.se/ledigajobb (https://www.skane.se/ledigajobb) you can see in which stage Region Skåne's recruitments are and how many have applied for the positions.

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