Quality Control Manager GMP

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.

Work description
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


Matching candidate:
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