Professional Services of Quality Control QC) Consultants (3) for NRC- Clinical Trial Material Facility (CTMF)

To engage qualified consultants to provide Quality Control (QC) support during the operationalization of the Clinical Trial Material Facility (CTMF), in compliance with Health Canada, Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, policies, and procedures.

The NRC has built a new permanent, Good Manufacturing Practices (GMP)-compliant Clinical Trial Material Facility (CTMF) at its Royalmount Avenue site in Montréal, where the facility and equipment completed the validation mid-2024. This facility will manufacture as a Contract (Development and) Manufacturing Organization (C(D)MO) vaccines and other biologic materials for clinical trials and manufacture its first GMP biologics batch early 2027.

This request for proposals includes 3 lots as follows: 1. Lot 1 - Senior QC: one resource working on establishing the right QC process adapted to Phase 1 and 2 manufacturing in a biomanufacturing facility. 2. Lot 2 - Junior QC: one resources working on all QC processes: documentation review, data entry, incoming documentation, raw material sampling, analytical method transfer. 3. Lot 3 - QC Sampler: one resource to perform EM sampling in the clean rooms (grade C and D).