Reporting to the Manufacturing Lead, the Manufacturing Specialist 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 Specialist 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 Specialist conduct clinical production activities in cleanroom cGMP environment.
- Processes cellular products according to batch record and standard operating procedure (SOP), using aseptic technique in an ISO Class 7 or 8 cGMP environment.
- Supports and assists the Manufacturing Lead in the creation and development of manufacturing batch record documentation, SOPs, deviations, change controls.
- Support for scientific documentary research and writing of complex technical documents.
- Assists in manufacturing batch record review and drug product release
- Provides input/feedback to Manufacturing Lead on documentation and process improvements.
- Uses a proactive and organized approach to accomplish deliverables.
- Actively participates in manufacturing meetings with the project team.
- Participates with the team on implementing the requested tasks of the backlog.
- 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, as required including environmental monitoring sampling.
- Supports the logistics team on inventory management, kit preparation and reporting on inventory status.
- Support the Manufacturing Lead on filling out the project specific documentation for Logistics.
- Champion of compliance. Maintains a quality-first mindset to deliver quality product for therapeutic treatments.
- Maintain consistent communication with management 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.
- Integrate best practices, where appropriate, into manufacturing.
Requirements, Knowledge, Skills and Abilities
- Master’s degree in Biology, Chemistry, Engineering or combination of BSc/TM
- Minimum 2 years of experience in cGMP or comparable environment is an asset AND/OR in cellular therapy
- Knowledge in the field of cell or gene therapy or biologics manufacture is an asset
- Good Scientific background
- 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
- Familiarized with electronic systems (such as timesheets and electronic batch record)
- Bilingualism is essential (French and English)
To apply for this position, please send a cover letter and resume to firstname.lastname@example.org, indicating the job title you are apply for in the subject line of your email.