EM Laboratory Supervisor

Job Title
: EM Laboratory Supervisor

Revision No.:
OBQCEMLEAD

Department
: Quality Control

Working Arrangement:
On Site

About OmniaBio:

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. OmniaBio 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, OmniaBio aims to enable broad access to cutting-edge therapies worldwide.

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Position Summary:

As the Microbiology EM Supervisor at OmniaBio, you are an experienced leader in the field of Environmental Monitoring for Good Manufacturing Practices (GMP) manufacturing. The Microbiology EM team is responsible for all Environmental Monitoring and APS programs and all outputs associated with each. The Microbiology EM Supervisor, will be required to work specifically to maintain the environmental conditions in clean rooms by managing the EM program, through EM sample management, data management and trending and the APS program through sample management, visual inspection of media fills and growth promotion testing of media. The successful candidate will demonstrate flexibility within the quality team 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.

Responsibilities:

• Delivers quality related services as contracted to various cell and viral product centered clients.
• Assists in building the OmniaBio EM program.
• Prepares and manages the EM schedule. Prepares and executes EM sampling for all in-suite activities.
• Reviews EM data and prepares trend reports.
• Reviews and approves applicable Microbiology documentation.
• Performs room status updates, and, in collaboration with clients, ensures all EM documentation is complete and available for approval.
• Prepares and executes other EM related study protocols and reports.
• Collaborates with the Production, Manufacturing Science and Technology (MSAT), Facilities, Sterility Assurance (SA) and QC teams in the preparation of EM strategy and execution. Collaborates with peers to co-create solutions to remediate compliance and quality issues.
• Provides in-suite and on-the-floor support for OmniaBio's manufacturing teams, ensuring a compliant and fast-to-patient mindset
• Performs and maintains EM material testing in compliance with approved and current specifications.
• Designs, organizes and maintains the standard operating procedures (SOPs) that describe our equipment's key functions, including operations and maintenance procedures.
• Facilitates the training of end-users on sampling requirements, sample handling and other quality procedures, as applicable.
• Creates equipment logbooks/records and a preventative maintenance schedule for applicable equipment.
• Manages the third-party testing by approved partners and takes part in the qualification processes of third-party laboratories, as needed.
• Performs and maintains aseptic gowning qualification and personnel qualifications.
• Participates in client audits and health authority audits, as required.
• Prepares, reviews and manages EM related deviations, corrective and preventative actions, change controls, etc.
• Ensures GMP is embedded in all manufacturing-related tasks.
• Engages and supports 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 regenerative medicine fields.

Requirements:

• Bachelor's degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.). Microbiology background is preferred.
• 8+ years of experience in a cell therapy/viral quality department supporting GMP production or similar within the pharmaceutical, medical technologies, biologics or similar industries.
• Strong understanding of aseptic/sterile environments and technologies.
• Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and QA principles.
• Contamination Control experience for the development and maintenance of internal programs

Desired Characteristics:

• Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO or medical device development.
• Independent, detail-oriented self-starter with excellent analytical skills and able to multitask and succeed in a team environment.
• Experience in establishing customer-facing organizations and service models.
• Demonstrates initiative and the ability to deliver high-quality outcomes.
• Capable of managing multiple projects simultaneously
• Possesses strong verbal and written communication skills and is able to craft and deliver excellent presentations
• Experienced in driving results and influencing without authority in a highly cross-functional environment.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

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. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.