The Cellular Therapy Facility provides hematopoietic stem cells, other blood cells, and non-hematopoietic cells derived from a variety of sources (bone marrow, peripheral blood and various tissues) for hematopoietic reconstitution, immunotherapy, and regenerative medicine applications. These clinical products are manufactured to meet Good Manufacturing Practice standards (GMP) from the receipt of starting materials through to delivery of the product to the patient/clinical site.The program is integrated with clinical teams for both the collection of patient-specific manufacturing starting material and the ultimate release of the product for clinical use.

The Cell Processing Specialist is responsible for manufacturing cell therapy products that run the range of minimally manipulation to participating in the manufacturing of more complex products in GMP compliance.

The Cell Processing Specialist is responsible for daily operations within the Cellular Therapy Facility operated by the Blood & Marrow Transplant/CT Program.They will be involved in cell acquisition, testing, purification, cryopreservation, storage, and release to the bedside – including but not limited to allogeneic and autologous products collected at SickKids as well as other national/international centers.

The successful candidate will work in our state-of-the-art facility within a team of cell specialists. Their work will include management of day-to-day laboratory operations, including inventory management, equipment validation and maintenance, coordination with the clinical teams in acquisition and release of clinical products.They will also be involved in learning and implementing new manufacturing processes and equipment to promote continued optimization and advancement of manufacturing technologies.

The Cellular Therapy Facility operates within the BMT/CT program and hence is integral to program quality initiatives.The Cell Processing Specialist will be involved with audits and quality reviews for both the Facility and the BMT/CT program.

The Cell Processing Specialist will act in accordance with the mission, vision, values, and goals of the Hospital.

Here’s What You’ll Get To Do:

• Process human cellular products, including bone marrow, hematopoietic progenitor cells, and other cells derived from blood/bone marrow/other tissue using aseptic technique according to approved SOPs and in compliance with GMP requirements.

• Liaise with physicians, nurses, translational researchers, research coordinators, quality control and quality assurance staff, and external clients to ensure timely availability of cell therapy products and compliance with study/regulatory requirements.

• Assist clinical staff with cell collections and product infusions

• Coordinates and/or performs product characterization and release assays and integrates these results in the product records.¿¿

• Completes and compiles all required documentation (including batch records and final Certificate of Analysis) for inclusion in processing records and performs data assessment for compliance and product release.

• Performs error-free calculations to determine cell counts and viability, dilutions, and cell concentrations.

• Reports deviations and variances to facility management and BMT physicians in a timely fashion and participates in investigations and audits.

• Assist with specification and deviation investigation reports, change controls, Corrective and Preventative Actions (CAPAs).

• Assists with reagent, supplies, and patient product inventory management to ensure operational readiness

• Performs routine facility maintenance as scheduled and maintains quality control records in compliance with GMP.

• Executes validation protocols including the use of biological safety cabinets, incubators, centrifuges, cell sorting technologies, cell washing equipment, controlled rate freezers, bioreactors and other automated cell expansion systems as required.

• Assists with proficiency testing, validation and implementation and update of cell processing procedures and test methods, as directed.

• Participate in in-house, client and regulatory audits as required.

• Maintains technical and regulatory proficiency in all areas of laboratory operation applicable to cell processing

• Contributes to the writing, review, and implementation of SOPs that meet regulatory and GMP requirements.

• Assist with the training of new Facility members, clinical trainees, and quality specialist as needed

• Attends¿GMP¿training webinars, job-related seminars and weekly meetings.

• Occasional on-call/weekend hours as clinical demands arise.

Here’s What You’ll Need:

• Graduate of Medical Laboratory Sciences program with certification in Laboratory Medicine or a Bachelor’s degree in Biology/Life Sciences with 2+ years cell culture experience is preferred

• An understanding of cell biology and immunology as well as experience in cell culture and aseptic technique is required

• Clinical laboratory experience in a related area such as blood banking preferred

• Strong attention to detail required

• Ability to troubleshoot and problem solve

• Ability to function both independently and within a team environment

• Strong communication skills

• Ability to perform arithmetic calculations

• Knowledge on computer systems and software used in functional area (MS Word, Excel, PowerPoint, databases)

• Experience in manufacturing cell therapy products, including but not limited to following SOPs, knowledge of GMP regulations, batch record, and use of automated cell therapy production equipment an asset

Employment Type: Full-time, 14-month contract with health and dental benefits

The children and families we care for are from a variety of communities, and so are our employees. We welcome and encourage everyone to join our organization and be part of our team.

When requested, SickKids will provide access and inclusion supports to eligible candidates to support their full engagement during the interview and assessment process. Information received related to access or inclusion will be addressed confidentially.

Thank you for your interest in joining SickKids. Only those applicants selected for an interview will be contacted. In accordance with our Hospital policy, employment at SickKids is conditional upon the Hospital’s receipt of all necessary documentation.

FOR EXTERNAL APPLICANTS ONLY: As a health care institution, our highest priority is the safety of patients, families and staff. As a result, we are adopting all prevention measures to ensure the safety of our patients, families and our staff. Therefore, any offer of employment is conditional upon you submitting proof that you have been fully vaccinated with a Health Canada or World Health Organization (WHO) approved COVID-19 vaccination as soon as possible and no later than fourteen (14) calendar days prior to the effective start date, in addition to satisfying any other condition(s) that may be set out in an offer. If a candidate fails to satisfy this condition (or any other condition(s) set out in an offer), any offer of employment shall be immediately rescinded.

How to Apply

Tip: Combine your cover letter and resume into ONE document of 20 pages or less as you cannot upload multiple documents as part of your application.

If you are still experiencing technical difficulties please email ask.hr@sickkids.ca to send us a short description of the issues you are experiencing. Please note that we will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.