GMP Cell Production Associate

Company:
Takara Bio Europe (formerly Cellartis), a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells (hPSC), including both iPS cells and ES cells and related media development. The company leverages long-standing experience in stem cell reprogramming, CRISPR gene editing, scale-up and differentiation into many different types of mature and functional human cells.

Takara Bio Europe AB has GMP facilities for production of human pluripotent stem cell lines and their derivatives intended for use in cell therapy under MPA and FDA regulations. The company is located in Gothenburg, Sweden.

About The Position:
We are looking for a detail-oriented person to join our cell manufacturing team. The role is laboratory-based and the selected candidate is expected to work in our team for stem cell based manufacturing activities, mainly in our GMP facility but also in our research grade laboratory when required. As part of your duties, you will also participate bioprocess development of our cell manufacturing and tech transfer to the GMP facility.

Responsibilities:
· Team member in our cell manufacturing team.
· Production of stem cell related products and services.
· Work in our GMP facility as well as the research grade laboratory.
· Work according to GMP production schedules and instructions (e.g., SOP, MBR)
· Prepare, review, and revise GMP documentation.
· Initiation and handling deviation, change control, CAPA.
· Support tech transfer activities from the internal and external.
· Identify, evaluate, and implement new processes for production of existing cell products.
· Participate in implementation of new products and services.
· Works in close collaboration with supply chain, QA/QC, QP team.
· Additional duties as assigned.
· Work on weekends on monthly basis.

Qualifications:
· BSc/MSc/PhD in Cell Biology, Molecular Biology, Microbiology, Pharmacy, or related field.
· >3 years biological manufacturing relevant experience, preferably in the biotech, biologics and/or pharmaceutical area.
· Exposure to ISO 9001, ISO 13485 quality management system is an asset.
· Good understanding and application of GMP and regulatory requirements is preferred.
· Experience of work in clean room area within GMP is preferred.
· Experience of work with ATMP products is an advantage.
· General knowledge of biological raw materials, cell culture and cell culture media.
· Hands on experience with mammalian cell culture and aseptic techniques. Experience in culture, differentiation of pluripotent stem cells and scale-up bioprocessing (e.g. Cell Factory for adherent cell culture, Bioreactor for cell suspension culture) is an asset.

The position is permanent and full time.

We’re a team of highly motivated and skilled people who want to make a difference. Do you want to join us? You will get friendly, motivated and skilled colleagues with whom you can both laugh and work.

You are welcome with your application no later than August 31st, 2022. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Dr. Yu Zhang (yu_zhang@takarabio.com)

You can find out more about Takara Bio at https://www.takarabio.com
Life in Gothenburg: https/www.movetogothenburg.com