Senior Manager, Raw Materials

Overview

Based in Toronto, Ontario or Cambridge, MA, USA, the Senior Manager of Raw Materials will lead the technical oversight and lifecycle management of raw materials used in our internal and externally partnered pipeline programs. This role ensures materials are fit-for-purpose, phase appropriate, and consistently available to support research, process development, and clinical cell therapy operations. As a technical SME, the manager will own the characterization, qualification, and ongoing performance monitoring of raw materials—such as cytokines, serum, media, viral vectors, reagents, and single-use consumables—used throughout our cell therapy processes.

The SME will also be accountable for supporting clinical operations with deviation investigations, OOS/OOT assessments and CAPA implementation. The role is responsible for authoring Blue Rock’s raw material business process and overall raw material control strategy. The leader will chair the internal Raw Material Review Committee, partner cross-functionally to influence raw material selection, partner with Supply Chain to steer key vendors and lead internal & external resources to perform lifecycle management on raw materials and drive targeted continuous improvements.

The leader will be responsible for onboarding contract staff to support peak workloads (i.e. new tech transfers). The position reports to the VP Engineering & MSAT. The Senior Manager must excel in fast-paced environments, be able to execute on functional builds relevant to the raw material business process while delivering on deliverables to progress pipeline assets. This leader will engage with all technical (Research, Process Development, Manufacturing, MSAT, TDT Leads) and non-technical departments (Supply Chain, Procurement) as it relates to raw materials.

• Represent the MSAT function in cross-functional teams as a materials science SME for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.
• Support creation and maintenance of the raw material lifecycle management process for CGMP operations.
• Provide technical input into raw material change controls and deviations to ensure strong scientific and compliance decision-making.
• Lead root cause analyses and corrective/preventive actions for raw material deviations or performance inconsistencies.
• Serve as the SME for raw materials used in cell therapy manufacturing, including qualification, characterization, risk assessment, and lifecycle management.
• Develop and maintain raw material specifications and testing strategies aligned with regulatory expectations for advanced therapies.
• Drive raw material control strategies, focusing on biological variability, contamination risks, and general process criticality.
• Own the risk management framework for raw materials, including contamination control, variability mitigation, and tiered supplier oversight strategies.
• Support new material introductions, ensuring technical assessment, validation readiness, and compliance with CGMP requirements.
• Partner with Supply Chain and Quality to qualify suppliers, including technical evaluations, supplier capability assessments, and Material Qualification (MQ) activities.
• Lead technical interactions with suppliers, including troubleshooting, raw material investigations, and support of supplier-driven changes.
• Evaluate and qualify alternate suppliers in partnership with users as appropriate.
• Partner with Process Development to ensure materials selected in development are robust for planned scale-ups.
• Collaborate with Quality Control to develop or refine raw material testing methods, including methods for biologically complex inputs.
• Provide regulatory support for IND/BLA submissions, specifically around raw material control strategies, supplier qualification, and risk management.
• Establish workflows, prioritization strategies, and performance metrics for raw material lifecycle management.
• Foster a culture of scientific rigor, operational excellence, and proactive risk identification.

• Bachelor’s degree or higher in life sciences with 13+ years of experience including 11+ years in a biopharma…