GMP Facility Manager at Takara Bio Europe AB

Takara Bio Europe AB, 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. The company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. Takara Bio Europe AB has GMP facilities for production of (i) pluripotent stem cell lines for use in cell therapy and (ii) GMP grade cell culture media. The company is located in Göteborg, Sweden.

We are looking for an enthusiastic, problem-solving, and driven person who enjoys working with a team in a product & service-oriented environment. The GMP Facility Manager is an engineer/laboratory technician, preferably with experience from the pharmaceutical industry. The GMP Facility Manager will work in close collaboration with Qualified Person (QP) as well as with the Managers for Cell Production and Media Production.

Key requirements:
· Relevant education on MSc level such as an engineering degree with a life science profile
· Experience with GMP manufacturing, preferably of ATMP products, or experience in other regulated industry, such as medical devices, biologics, or diagnostics
· Significant knowledge of GMP regulations
· Excellent communication and collaboration skills
· Good in creating and following up plans and schedules
· Good leadership skills

General tasks and responsibilities include:
· Coordinating the maintenance of the GMP Manufacturing facilities and the non-classified laboratories.
· Ensuring cleanrooms and equipment are monitored, maintained and available for production.
· Drafting facility annual expense and capital budgets and preparing annual maintenance and calibration plans.
· Performing maintenance and calibration in collaboration with team members and external suppliers.
· Administering the facility related SOPs.
· Providing support for the production and QC teams in problem-solving related to maintaining quality compliance. Directing SOP preparation, adherence and compliance.
· Together with the QP, accountable for continuous audit readiness for GMP inspections.
Providing support for the facility’s consistent adherence to compliance through participation in internal and external audits.

· Training and mentoring of team members.
· Additional duties as assigned


We are a highly motivated and skilled team that wants to make a difference. Do you want to join us? You will get friendly, supportive and competent colleagues with whom you can both laugh and work.
You are welcome with your application anytime before October 1, 2021. Please note that we will have an ongoing review of candidates.

For more information about the position, please contact Kristina Runeberg, Site Head, (kristina_runeberg@takarabio.com).

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