Manufacturing Project Lead

The Manufacturing Project Lead is responsible for leading a team of manufacturing associates in the execution of cell and gene therapy production projects within the cleanroom environment. This role will be integral part of tech transfer and work closely with MSAT to onboard client projects and develop project specific training for the execution team. This role serves as the subject matter expert (SME) for manufacturing processes and activities, ensuring compliance with GMP standards and supporting continuous improvement. The Project Lead acts as the primary technical resource for the team and provides oversight and mentorship to assigned staff at OmniaBio’s Hamilton, Ontario, facility. This position is site-based, with work hours adhering to a designated pattern of 12-hour shifts.

Responsibilities

• Lead day-to-day manufacturing activities for assigned project, ensuring adherence to SOPs, GMP, and safety protocols.
• Serve as the SME for cleanroom operations, troubleshooting process issues and providing technical guidance.
• Lead and mentor Manufacturing Associates, providing training and performance feedback.
• Support tech transfer operations through close coloration with MSAT on equipment selection, room layouts, batch record development, staff requirements, scheduling and training.
• Client communications and interaction supporting tech transfer and batch production.
• In conjunction with MSAT and the training supervisor, develop and provide project specific process training.
• Support supervisors in project and staff scheduling.
• Coordinate with Supply Chain and Quality teams to ensure materials and documentation are in place for project execution.
• Support equipment commissioning, qualification, and validation activities.
• As project SME, participate in investigations of non-conformance events and contribute to root cause analysis.
• Drive continuous improvement initiatives within the team.
• Ensure accurate and timely completion of batch records and documentation.
• Communicate project status and issues to the Manager / Supervisor and other stakeholders.
• Helps drive standards to ensure a successful work environment.
• Utilizes the SAP enterprise resource planning system to support manufacturing activities.

Qualifications

Desired Characteristics

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