Supervisor, Quality Control Microbiology

6 months ago


Toronto, Canada Centre for Commercialization of Regenerative Medicine Full time

**About CCRM**:
CCRM, based in Toronto, Canada, is a unique not-for-profit group that is developing and commercializing cell and gene therapies and regenerative medicine technologies. We are leveraging our network of academics, industry partners and investors to tackle significant problems and advance our most promising technologies to the market to meet the needs of patients. For more information about CCRM, please visit our website at ccrm.ca.

**Department**: Quality Control

**Role Summary**:
As Supervisor, Quality Control (QC), Microbiology, at CCRM, you will be part of a diverse team focused on designing and implementing QC programs within the cell and gene therapy and regenerative medicine fields. You will provide technical expertise and work within the team to define and execute project tasks and day-to-day operational duties. As a QC team member, your work will ultimately support CCRM in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative medicine.

**Responsibilities**:

- Maintains a level of expertise in the Microbiology team regarding equipment and operations to support manufacturing for CCRM and its clients.
- Supervises the environmental monitoring (EM) program, and provides technical and administrative support for activities related to EM.
- Assists EM technicians in sampling and with other EM responsibilities when required.
- Performs QC microbiology testing and supports any outsourced testing for lot release/stability studies.
- Reviews standard operating procedures (SOPs) as necessary; recommends changes and updates, and initiates change controls, as needed.
- Performs and maintains EM tracking and trending of data in a timely manner.
- Assists with gowning qualification program.
- Manages material inventory required for the EM program.
- Ensures equipment is maintained in good order; coordinates with the Facility team to perform calibrations and qualifications, as required.
- Performs investigations, deviations or other quality events related to EM and ensures the closure of the associated reports in a timely manner.
- Closely interacts with the Manufacturing and Quality departments for all aspects of EM.
- Trains and mentors QC associates in their work. Maintains QC associate work schedule and project plans, in accordance with project timelines and key milestones.
- With the aid of the Manager or Director, QC, manages resource allocation to ensure the project needs are met.
- Provides technical expertise to help create an aseptic strategy for CCRM manufacturing to implement in the Centre for Cell and Vector Production and other CCRM-managed sites.
- Designs, organizes and maintains the SOPs that describe EM equipment key functions, including, but not limited to, the operations and maintenance procedures.
- Analyzes existing microbiology SOPs for content, focusing on technical requirements.
- Facilitates the training of end-users on EM sampling requirements, sample handling and other procedures, as applicable.
- Creates equipment logbooks/records and a preventative maintenance schedule for applicable equipment.
- Maintains equipment, monitors process areas, and ensures they are prepared for use.
- Manages third-party testing by our approved partners and takes part in the qualification of third-party laboratories, as needed.
- Supports validation by collaborating and reviewing qualification protocols, executed protocols and summary reports.
- Adheres to Good Manufacturing Practices (GMP) in everyday tasks.
- Demonstrates CCRM’s values of purpose, integrity, excellence, accountability and collaboration, and motivates others to do the same.
- Continuously grows and adapts in a fast-moving industry to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.
- Performs any other tasks/duties, as assigned by management.

**Qualifications**:

- Bachelor’s degree in microbiology, biology or related scientific field with 4-5 years of GMP experience.
- Previous experience working in EM/sampling, writing EM protocols and EM investigations, and leading gown qualification program required.
- Minimum 1-2 years of supervisory experience preferred.
- Able to work well with others and independently.
- Able to manage and coordinate multiple projects in a fast-paced environment.
- Strong English written and verbal communications skills.

**Desired Characteristics**:

- Understanding of Health Canada/US Food and Drug Administration GMP regulations and quality assurance principles.
- Proven experience writing GMP documents (i.e., SOPs, validation procedures).
- Able to deliver high-quality work with specific attention to detail.
- Able to quickly grasp complex technical concepts and make them easily understandable in text and pictures.
- Excellent communication and interpersonal skills with assertive, responsible and accountable attitude.
- Strong working knowledge of Microsoft Of



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