Reporting to the Manufacturing Lead, the Manufacturing Technologist is part of the Cellular Manufacturing Unit of C3i – the most advance production team of cells therapies in Canada, located at the Centre of Excellence in Cellular Therapy (CETC), a state-of-the-art cGMP facility.
The Manufacturing Technologist supports process tech transfers, cGMP production activities, and technology improvements towards the successful delivery of released product to meet the needs of a client’s clinical trials. The Manufacturing Technologist conducts clinical production activities in cleanroom GMP environment.
Responsibilities
- Processes cellular products according to batch records and standard operating procedures (SOP), using aseptic technique in an ISO Class 7 or 8 cGMP environment.
- Provides input/feedback to Manufacturing Lead on documentation and process improvements.
- Prepares cleanrooms and equipment for product manufacturing.
- Uses a proactive and organized approach to accomplish deliverables.
- Participates in manufacturing meetings with the project team.
- Successfully troubleshoots processing and equipment issues with the instructions of the SME (Subject Matter Expert).
- Supports Operation’s team in all areas of cell culture and all related duties, including environmental monitoring sampling.
- Supports the logistics team on inventory management, kit preparation and reporting on inventory status.
- Champion of compliance. Maintains a quality-first mindset to deliver quality product for therapeutic treatments.
- Maintains consistent communication with leadership and team and inform the arrival of unexpected work to prioritize it correctly.
- Ensures the timely completion of the routine maintenance and cleaning of rooms and equipment.
Requirements, Knowledge, Skills and Abilities
Medical Technologist Diploma. The person must have knowledge of medical laboratory techniques acquired through theoretical and practical training provided by a school of medical technology or a recognized college-level institution by the Ministère de l’Éducation.
Member of the OPTMQ (Ordre Professionnel des Technologistes Médicaux du Québec)
- Ability to follow detail technical instructions
- Detail-oriented, pro-active and organized
- Team player
- Demonstrated aseptic techniques
- Flexibility to work weekends, overtime hours, and some holiday work as the case may arise
- Must be able to work in controlled environments requiring special gowning
- Bilingualism (French and English)
To apply for this position, please send a cover letter and resume to hr@centrec3i.com, indicating the job title you are apply for in the subject line of your email.