This competition is open to all applicants, however internal candidates and applicants who were former employees of the University of Alberta in the past 18 months will be given priority consideration before external candidates.
This one year term position offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits .
The Alberta Cell Therapy Manufacturing (ACTM), is recruiting a Cell Processing Specialist. The successful candidate will be responsible for manufacturing cell therapy products in compliance with Good Manufacturing Practice (GMP) for early phase clinical trials, assisting with translation of experimental cell production methods to GMP compliant protocols and for equipment and cleanroom operation and maintenance.
- Contribute to the development of cell production methods for GMP production using appropriate production equipment and raw materials.
- Contribute to protocol/batch record development.
- Assist in writing equipment Standard Operating Procedures and validation protocols for standard and automated cell production equipment in the GMP cleanrooms.
- Perform routine maintenance as scheduled and maintain records in compliance with GMP.
- Execute validation protocols as required.
- Operate the equipment as required including biological safety cabinets, incubators, centrifuges, cell sorting technologies, cell washing equipment, controlled rate freezers, bioreactors and other automated cell expansion systems.
- Participate in mandatory Regulatory Medical Screening.
- GMP production of cell therapy products from the receipt of starting materials through to delivery of the product to the clinical site.
- Work in a compliant manner in the cleanroom facility including wearing proper cleanroom attire, moving materials into the cleanroom according to documented procedures and assessing environmental monitoring parameters.
- Ensure that the manufacturing process is performed in compliance with approved SOPs and GMP requirements.
- Document production operations in corresponding batch records according to established procedures.
- Assist with specification and deviation investigation reports, change controls, Corrective, and Preventative Actions (CAPAs).
- Participate in in-house, client and regulatory audits as required.
- Bachelor’s degree in Biology/Life Sciences with 2+ years cell culture experience is preferred. A combination of education and experience will be considered.
- Expertise in cell culture and aseptic technique.
- Successful completion of Regulatory Medical Screening.
- Experience using automated cell therapy production equipment.
- Expertise in manufacturing of products following SOPs, batch records and working in a GMP environment.
- Ability to troubleshoot process and equipment problems as required.
- Strong attention to detail required. Strict adherence required to SOPs and GMP regulations including the ability to accurately complete documentation associated with clinical manufacturing.
- Strong technical writing skills and investigations skills.
Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.
We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.
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