Takara Bio Europe Swedish Filial (TBESF) located in Gothenburg, is focusing on stem cell-derived products, and services for cell therapy/regenerative medicine, drug discovery and disease modelling. The company leverages long-standing experience in stem cell handling and scale-up together with leading expertise in differentiation of cells into mature and functional human cells. Specifically, the company possesses broad expertise in human pluripotent stem cells, including hiPSC, hESC and related media. Takara Bio Europe has an established GMP laboratory for production of pluripotent stem cell lines and related media. For more information, visit our website: www.takarabio.com

To better support our GMP activities we are leveraging our Quality Control unit and adding QC capabilities for GMP products. We are looking for a Quality Control Manager GMP who will strengthen our team in the GMP QC area. We are currently setting up the facility and equipment’s, and you will continue this work to finalise the processes and procedures for the first assays. Once the first assays are established, you will work hands on in the lab together with QC colleagues. Compliance of the GMP QC lab and its processes along with implementation of any new assay will be your responsibilities. You will also manage our external GMP QC labs supplying us with the services not yet inhouse.

The person we are looking for is well experienced in bioanalytical methods like flow cytometry and PCR, have transferred and validated methods in the area and is familiar with cell culture. Communication skills are crucial as there will be many contacts with suppliers of equipment as well as of external QC services. This role requires good knowledge and adherence to Quality principles and standards, including pharmacopoeia methods. You will be part of the quality team and initially report to the Associate Director Quality.

Project phase:

• Drive the implementation of GMP QC assays at the site

• Set up agreements with QC suppliers for external services

• Ensure the equipment is qualified and the methods are validated

• Set up processes for and create SOPs

Operational phase:

• Lead the daily work in the GMP QC lab

• Hands on work in the GMP QC lab

• Keep the GMP QC lab, its processes and SOPs in compliance

• Maintain good relations with and evaluate QC service suppliers

• Implement new GMP QC assays and when required, sourcing of equipment

• Manage change controls and deviations and other quality processes in the GMP QC lab

• Host and support audits and inspections

• At least Masters Degree in Molecular Biology, Cell Biology or similar field

• Hands-on experience of work in the wet lab (at least FC and PCR)

• Broad knowledge in Quality principles and pharmacopoeia methods

• Experience of assay development and validation, preferably in GMP or ISO17025 certified lab

• Analytical mindset and troubleshooting skills

• Mammalian cell culture experience is an advantage

• Experience of work with ATMP products is an advantage

• Good communication skills

You will be an important part of our new area of GMP QC both during the implementation and later during the operational phase. There will be a variety of tasks including hands on work in the lab as well as setting processes and writing SOPs, therefore the ability to work independently is required. At the same time you are the main contact for our external QC suppliers requiring communication and cooperation skills. The Takara office in Gothenburg can offer you a familiar environment where each person is doing a difference. Our official language is English.

Welcome with your application no later than August 31, 2023. We will start the evaluation of candidates in mid-August.

For more information please contact anna_gunnerling@takarabio.com

phone +46 765 25 09 61