Alberta Cell Therapy ManufacturingUniversity of Alberta • Edmonton, Alberta, Canada
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Alberta Cell Therapy Manufacturing
University of Alberta
- Edmonton, Alberta, Canada
- Edmonton, Alberta, Canada
À propos
Location - This role is in-person. Work primarily takes place at North Campus, Edmonton.
Alberta Cell Therapy Manufacturing (ACTM) is a Good Manufacturing Practice (GMP) – compliant facility that manufactures cell therapy products and provides aseptic fill/finish for use in human clinical trials. ACTM operates under national and international regulatory frameworks, including Health Canada GMP requirements, and supports both internal and external clients.
The Operations Supervisor is responsible for the overall coordination, execution, and oversight of day-to-day manufacturing and facility operations within ACTM's 10,000 square foot GMP cleanroom facility. This position provides operational leadership to clinical manufacturing staff and ensures that all activities are conducted safely, efficiently, within budget, and in compliance with regulatory, institutional, and quality system requirements.
Reporting to senior ACTM leadership, the Operations Supervisor works closely with internal stakeholders, external clients, regulatory agencies, Facilities & Operations, Environmental Health & Safety, and vendors to ensure the effective delivery of clinical manufacturing services.
Responsibilities
Operational Leadership & Resource Management
Provide operational leadership, direction, and mentoring to manufacturing staff to ensure projects meet client timelines, budgets, protocols, SOPs, and GMP requirements.
Plan, coordinate, schedule, and prioritize multiple concurrent manufacturing projects across five GMP cell therapy cleanroom suites and an aseptic fill/finish suite.
Allocate human, material, and facility resources to meet project timelines and operational requirements.
Oversee recruitment, onboarding, training, performance management, and professional development of staff.
Ensure staff training programs and records comply with GMP and University requirements.
Serve as a primary production representative during client interactions, audits, and regulatory inspections.
Communicate project and operational status, risks, deviations, and outcomes to management, clients, and other stakeholders.
Prepare staffing, capital, and operating inputs for project quotations and budgets.
Act as a designate for senior leadership, as required.
Clinical Manufacturing Operations
Oversee and perform aseptic manufacturing operations for a diverse portfolio of cell therapy and aseptic fill/finish projects.
Ensure manufacturing activities comply with Health Canada GMP regulations, institutional policies, and approved protocols.
Coordinate the development, review, and approval of SOPs, batch records, validation protocols, and manufacturing documentation.
Oversee the GMP validation program, including equipment, facilities, utilities, processes, cleaning, and computerized systems, from planning through execution and approval.
Provide real-time operational decision-making during manufacturing activities to ensure quality, safety, and compliance.
Monitor project progress to ensure objectives are achieved in a timely and cost-effective manner.
Facility, Equipment & Quality Systems Oversight
Oversee the operation and maintenance of GMP-compliant cleanrooms, manufacturing equipment, and monitoring systems.
Oversee preventative maintenance, calibration, validation, environmental monitoring, and certification activities.
Manage facility monitoring systems that track critical environmental and equipment parameters.
Oversee inventory control, material quarantine and release, and storage of clinical trial products.
Lead continuous improvement initiatives, including change controls, investigations, deviations, and CAPAs.
Ensure documentation, records, and data integrity meet GMP and University standards.
Coordinate contractors, vendors, Facilities & Operations, Environmental Health & Safety, and Supply Management Services.
Qualifications
Diploma or degree in biological sciences or a related discipline.
Minimum 10+ years of experience in a GMP-regulated manufacturing environment.
Demonstrated experience in GMP documentation, regulatory compliance, and project coordination.
Supervisory experience, including staff training and performance management (formal supervisory training is an asset).
Experience providing technical and regulatory training to staff.
Strong written and verbal communication skills.
Demonstrated ability to exercise independent judgment, manage competing priorities, and lead operational teams.
Application Instructions
Click "Apply Now" to submit your resume and cover letter.
This position is subject to all applicable terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA).
This position offers a comprehensive benefits package .
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, Métis, 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. Learn more .
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, Métis 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'Université de l'Alberta s'engage à créer une communauté universitaire où chaque personne se sent valorisée, où les obstacles à la réussite sont éliminés et où des connexions enrichissantes peuvent se développer. Nous accueillons les demandes de toutes les personnes qualifiées. Nous encourageons les femmes; Premières nations, Métis et Inuits; membres des groupes minoritaires visibles; personnes handicapées; personnes de toute orientation sexuelle ou identité et expression de genre; et toutes les personnes qui peuvent contribuer à la diversification des idées et à l'université à postuler.
About The Team
The Faculty of Medicine & Dentistry 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.
Compétences linguistiques
- English
Avis aux utilisateurs
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