CanadaBuys #25-58248

The National Research Council Canada (NRC) is seeking a highly qualified consultant to provide Good Manufacturing Practices (GMP) Production Documentation and Technical Support for its Clinical Trial Material Facility (CTMF) in Montreal, Quebec. - Government Buyer: - National Research Council Canada (NRC), Human Health Therapeutics, Clinical Trial Material Facility (CTMF) - Scope of Services: - Professional consulting services to generate, review, and approve GMP production documentation, including: - Standard Operating Procedures (SOPs) - Logbooks - Validation protocols (IQ/OQ/PQ) and reports - Validation test scripts and studies - Deviation and CAPA records - Risk assessments - Material code specifications - Change control documents - Technical advisory support to the production manager - Support for Data Integrity Assessment and Validation PQs to enable bulk drug product manufacturing - Key Requirements: - Minimum 10 years of GMP production experience, including cleanroom and qualification activities - Experience in coordination, inventory management, and risk analysis - Bilingual proficiency (English and French) - Valid Canadian government security clearance - Compliance with GMP standards for clinical trial material production - Procurement Details: - Competitive, open bidding process - Selection based on lowest price - Contract duration: 30 weeks (approx. 6-7 months), with an option to extend for an additional 30 weeks - Expected workload: up to 1,200 hours per period, 40 hours per week - Locations: - Place of performance: NRC Clinical Trial Material Facility (CTMF), 6100 Royalmount Avenue, Gate 10, Montreal, QC - Contracting office: NRC, 1200 Montreal Rd M58, Ottawa, ON - OEMs and Vendors: - No specific OEMs or vendors are named, as this is a professional services contract

The National Research Council Canada (NRC) is seeking professional services for a GMP Production Documentation and Technical Support consultant for the Clinical Trial Material Facility (CTMF) located in Montreal, Quebec. The consultant will provide support to generate, review, and approve production documentation such as SOPs, logbooks, validation protocols, and reports, and act as a technical advisor to the production manager. The contract duration is approximately 6 months, starting in April 2026, to support the start of bulk drug product manufacturing at the CTMF. The procurement is conducted via a competitive open bidding process with selection based on the lowest price.