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Position Summary:

As the Microbiologist at OmniaBio, you are an experienced individual in the field of Microbiology for Good 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.

Responsibilities:

• 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 OmniaBio’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 deviations, corrective and preventative actions (CAPA), Change Controls, etc.
• Provide quality support for clients and third-party contract services when needed.
• Ensure GMP is embedded in all manufacturing related tasks.
• 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.

Requirements:

• 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.
• Strong understanding of aseptic / sterile environment and technologies.
• Excellent understanding of Health Canada/US Food and Drug Administration Good Manufacturing Practices (GMP) regulations and QA principles.
• Ability to meet Visual Exam Requirements

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 the ability to multitask and succeed in a team environment.
• Experience establishing customer-facing organizations and service models.
• Demonstrate initiative and the ability to deliver high quality outcomes in dynamic situations.

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.