OmniaBio: Microbiologist

Posted Friday, November 28, 2025 at 5:00 AM | Expires Thursday, January 1, 2026 at 4:59 AM

About Omnia Bio:

Omnia Bio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, Omnia Bio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, Omnia Bio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput.

This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. Omnia Bio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, Omnia Bio aims to enable broad access to cutting‑edge therapies worldwide.

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As the Microbiologist at Omnia Bio, you are an experienced individual in the field of Microbiology for Good Manufacturing Practices (GMP) manufacturing. The Microbiology EM team is responsible for all aspects of quality for the organization with respect to Environmental Monitoring and Aseptic Process Simulation (APS) visual inspection. Microbiologist will be required to work across the entire range of activities, including but not limited to maintaining the environmental conditions in our clean rooms by performing environmental monitoring, testing, sample management, equipment qualification, method suitability and data review and APS visual inspection and growth promotion.

You will demonstrate flexibility within the quality and larger organization, flowing to work priorities as required. Environmental monitoring (EM) is an enabling function and as such this role will support production and facility needs to ensure product supply to patients. You will ensure the high‑quality delivery of contract services.

• Deliver quality control microbiology related services including environmental monitoring, sample management, testing, method suitability, data review and equipment management.
• Collaborate with Production, Manufacturing Science and Technology (MSAT), Facilities and QC in the preparation of environmental monitoring strategy and execution.
• Maintain the EM schedule.
• Perform material testing in compliance with approved and current specifications, including but not limited to, incoming materials, in-process materials, drug substance materials, drug product materials, environmental monitoring samples and stability samples.
• Design, organize and maintain the Standard Operating Procedures (SOPs) that describe our equipment’s key functions including operations and maintenance procedures.
• Facilitate the training of end‑users on sampling requirements, sample handling and other quality procedures (if applicable).
• Create equipment log‑books/records and a Preventative Maintenance (PM) schedule for applicable equipment.
• Review and approve Microbiology documentation as required.
• Maintain the sample management program, including sample identification, storage and retention.
• Facilitate the third‑party testing by our approved partners and support the qualification processes (as needed) of third‑party laboratories.
• Perform aseptic gowning qualification and maintain personnel qualifications.
• Provide in‑suite and on the floor support for Omnia Bio’s manufacturing teams, ensuring a compliant and fast to patient mindset. Plan and execute EM sampling for all in‑suite activities. Collaborate with production, QC and Facility peers, to co‑create solutions to remediate compliance and quality issues.
• Perform room status update, in collaboration with client, ensure all EM documentation is complete and available for approval.
• Participate in Client audits and Health Authority audits as required.
• Prepare, review and assess…