Manager MSAT

The Manager, MSAT will play a key role in building and scaling Manufacturing Science & Technology capabilities within a growing GMP manufacturing environment. This role is responsible for supporting technology transfer, process validation, and commercial manufacturing readiness across API and sterile product programs.

Reporting directly to the VP, Technical Operations & Quality, this individual will act as a trusted technical partner—helping translate strategy into execution, establishing structure, and enabling reliable, compliant manufacturing as operations scale.

The role sits within a highly collaborative technical organization and works closely with cross-functional teams including Technical Operations, Quality, Engineering, Manufacturing, and Program Management.

Key Responsibilities

• Lead process development, scale-up, and validation activities from development through commercial GMP manufacturing
• Establish and implement MSAT processes, tools, templates, and SOPs
• Support technology transfer activities to ensure smooth handoff into manufacturing
• Author and review technical documentation including protocols, reports, batch records, deviations, and change controls
• Develop and execute process and cleaning validation strategies
• Conduct process risk assessments, gap analyses, and fit-to-plant evaluations
• Partner with Engineering and Operations on equipment selection, process design, and facility readiness
• Support media fill planning, execution, and reporting
• Provide MSAT support during regulatory inspections and audits
• Act as a technical bridge between development, quality, engineering, and manufacturing teams
• Promote a strong GMP culture and continuous improvement mindset

Qualifications

• Master’s degree in Chemistry, Pharmacy, Chemical Engineering, or a related discipline
• PhD strongly preferred
• 5+ years of experience in MSAT, validation, or process qualification within a GMP-regulated pharmaceutical environment
• Strong knowledge of GMP requirements (Health Canada, FDA, EU)
• Experience supporting sterile manufacturing environments
• Proven ability to generate and manage regulatory-ready documentation
• Experience supporting regulatory inspections
• Six Sigma and/or PMP certification considered an asset

Key Attributes

• Builder mindset with comfort creating processes and structure from the ground up
• Strong technical judgment and risk-based decision making
• Collaborative and cross-functional working style
• Comfortable operating in fast-growing, evolving environments
• Clear communicator able to translate complex technical concepts
• Hands-on approach with the ability to balance execution and leadership

Additional Information This is a net new role created to support continued growth and expansion of manufacturing operations.
Compensation:
Competitive base salary in the range of $100,000 – $140,000, plus comprehensive benefits and additional total rewards.