Sr. Manager, Raw Materials - MSAT

Job#: 3034064

Job Description:

Title:Senior Manager, Raw Materials - MSAT

Client: Biotechnology company

Contract/Perm & duration: 12-month contract (possibility of extension/conversion)

Location: remote, with some travel

Pay Rate: $75-82/hr

Description of Position:

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 support 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 partner with technical operations and quality teams with deviation investigations, OOS/OOT assessments and CAPA implementation. The role will contribute to the development of the client's raw material business process and overall raw material control strategy.

As a well-structured leader, the manager will support the coordination and facilitation of 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 & externals resources to perform life cycle management on raw materials and drive targeted continuous improvements. As needed, the manager may also support onboarding and coordination of additional contract staff to support peak workloads ( new tech transfers).

The position reports to the VP Engineering & MSAT.

The Senior Manager must excel in fast-paced environment, be able to execute on functional builds relevant to the raw material business process while executing 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.

Responsibilities:

·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.

·Partner with Quality to 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.

Minimum Requirements:

• Bachelor’s degree or higher in life sciences field with 13+ years of experience including 11+ years in a biopharma setting required.
• Advanced degree (MS/ Eng Doc) in Science/Engineering is preferred.
• Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and CGT materials.
• Extensive experience with cell and gene and biologics process development and cGMP manufacturing.
• Experience with cGMP regulations/guidance and regulatory agency inspections.
• Experience with continuous improvement, proficiency with operational excellence preferred.
• Strong interpersonal skills to effectively communicate with a diverse wide customer base.
• Strong planning and organizational skills.
• Good oral and written communication skills.
• High level of urgency and is able quickly adapt to changing priorities.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Everforth Apex Benefits Overview: In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.