OmniaBio 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, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio 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. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting-edge therapies worldwide. As the Microbiologist at OmniaBio, you are an experienced individual in the field of Microbiology for Valuable Manufacturing Practices (GMP) manufacturing.

The Microbiology EM team is responsible for all aspect 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. 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. Facilitate the training of end-users on sampling requirements, sample handling and other quality procedures (if applicable).

Review and approve Microbiology documentation as required. Facilitate the third-party testing by our approved partners and support the qualification processes (as needed) of third-party laboratories. Collaborate with production, QC and Facility peers, to co-create solutions to remediate compliance and quality issues.

Provide quality support for clients and third-party contract services when needed. Engage and support the OmniaBio Operating Model (OBOM) continuous improvement philosophy.



Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

Represent

OmniaBio and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits. Bachelor’s degree in science (bioengineering, bioprocess, biotechnology, cell biology, microbiology, etc.). Microbiology background preferred. ~6+ years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries. ~ Excellent understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles. ~ Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.

Experience establishing customer-facing organizations and service models. Demonstrate initiative and the ability to deliver high quality outcomes in dynamic situations.

Contract Quality Assurance An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity. OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position.

📌 Microbiologist (Contract) (Canada)
🏢 OmniaBio
📍 Canada