Job Description

Job Category: Technical - Science & Health
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This position is a part of the Non-Academic Staff Association (NASA).
This position offers a .
Location - This role is in-person at North Campus Edmonton.
The Department of Surgery has 15 divisions and offers programs in undergraduate, graduate and postgraduate studies. The department also includes many other research groups who contribute to cutting edge advancement in areas such as transplantation, joint preservation and regeneration and surgical simulation technology. Founded in 1922, the department has been a leader in its field, striving to achieve a balance between technology and the human element that defines the art of surgery. The overarching mission of the department is to restore health through surgical intervention, and to remember that patient dignity and comfort are integral to overall health. Further information on the department can be found at www.ualberta/ca/surgery.
The incumbent will be responsible for manufacturing cell therapy products in compliance with Good Manufacturing Practice (GMP) for use in human clinical trials, translation of experimental cell production methods to GMP compliant protocols, and equipment and cleanroom operation and maintenance.
Responsibilities:

• 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.
• Regulatory Medical Screening required
• 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.

Qualifications:

• 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 is essential. Experience using automated cell therapy production equipment is an asset.
• Expertise in manufacturing of products following SOPs, batch records and working in a GMP environment is an asset.
• 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.

Application Instructions
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About Us:
The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Metis, Inuit and all FirstPeoples of Canada, whose presence continues to enrich our vibrant community.
The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.
Your work will have a meaningful influence on a fascinating cross-section of people - from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. .
At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.
We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.
All University employees have a responsibility to foster a workplace that prioritizes safety in all its forms-physical, cultural, and psychological. This is achieved by promoting a safe environment, adhering to all safety laws, policies and procedures, completing all required safety training, identifying hazards and implementing controls, reporting incidents, and contributing to a culture of belonging and respect, while endeavoring to ensure that all colleagues feel valued and safe to express their thoughts, perspectives and concerns.
The University of Alberta is committed to creating a university community where everyone feels valued, barriers to success are removed, and thriving connections are fostered. We welcome applications from all qualified persons. We encourage women, First Nations, Metis and Inuit persons, members of visible minority groups, persons with disabilities, persons of any sexual orientation or gender identity and expression, and all those who may contribute to the further diversification of ideas and the University to apply.
L'Universite de l'Alberta s'engage a creer une communaute universitaire ou chaque personne se sent valorisee, ou les obstacles a la reussite sont elimines et ou des connexions enrichissantes peuvent se developper. Nous accueillons les demandes de toutes les personnes qualifiees. Nous encourageons les femmes; Premieres nations, Metis et Inuits; membres des groupes minoritaires visibles; personnes handicapees; personnes de toute orientation sexuelle ou identite et expression de genre; et toutes les personnes qui peuvent contribuer a la diversification des idees et a l'universite a postuler.
About the Team: The is one of the world's top academic health science centres. With 21 departments, multiple research institutes and centres, and a focus on excellence in education, research, and clinical care, the faculty trains outstanding medical and dental professionals and drives global health innovation in collaboration with partners across sectors.

Skills Required