Centre for Commercialization of Regenerative Medicine Hiring for Operations Supervisor at Toronto, ON 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 http://www.ccrm.ca.

Job Title: Operations Supervisor

Role Summary:
As an Operations Supervisor at CCRM, you will be part of a diverse bioengineering team focused on designing and implementing good manufacturing practices (GMP) production projects for CCRM’s GMP facility. You will provide technical expertise and will work with the team to define and execute project tasks. You will be an operations leader in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy and regenerative Medicine. Your role will act as support to the Operations Manager.

Responsibilities:

• This position will have responsibilities in CCRM’s GMP facilities.
• Ensure that all daily and weekly production schedules are met and coordinating with cross functional teams.
• Extract information from equipment manuals and other source documents, and write easy-to-understand, simple, user-friendly standard operating procedures (SOPs) that describe the equipment, key operating parameters, maintenance, and cleaning procedures.
• Responsible for maintaining equipment in good working order including compliance to the calibration, preventive maintenance, and re-qualification requirements.
• Train end-users on equipment operation, maintenance, and other quality procedures.
• Design/execute production batch records or other documents (i.e., validation protocols) that meet applicable standards and are appropriate for the intended audience.
• Ensure the CCVP facility is always maintained in excellent cGMP conditions.
• Drive continuous improvement of processes, facilities, and equipment.
• Prepare and review standard operating procedures (SOPs) related to facility, equipment, and processes for the CCVP facility.
• Initiate, investigate and perform corrective actions for Manufacturing related deviations, investigations and CAPAs for all levels of complexity and scope.
• Initiate Document Change Requests: author, revise, and review manufacturing documentation.
• Adhere to cGMPs and GDP (good documentation practices).
• Operate pilot-scale bioprocessing and interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Quality Assurance, Supply Chain and Process Development Technology Transfer counterparts.
• Support technology transfer of new product(s) in parallel with project and ensure GMP readiness to manufacture on time.
• Leads colleagues to identify resolutions for very complex and multifaceted problems.
• Provides deep technical expertise and guidance across the department. Acts as resource across multiple projects. Train and mentor staff on advanced experimental design and statistical data interpretation.
• Technical champion to the organization within their area(s). Provides formal or informal mentoring across the organization.
• Technical and moral role-model across the organization and actively identifies opportunities to proactively mentor team members.

Leadership Responsibilities:

• Provides supervision and training to Operations Associates and ensures all operations are performed according to standard operating procedures and health & safety procedures.
• Provide guidance to Operations Associates on proper GMP recording of entries and comments in batch records, forms.
• Implement a program to monitor and control operations from an employee safety perspective.
• Assist in the training of employees in aseptic processing and build high performing team.
• Provide technical expertise as an SME to the project team and execute the project to plan.
• Independently plans, executes, and analyzes complex tasks for multiple projects.
• Capable of designing plans for multiple projects with review by senior leadership.
• Identifies gaps across the business unit and guides others to develop techniques and procedures to fill those gaps.
• Communicates well across project teams in a leadership role. Independently initiates and/or lead collaborations with other business units within organization or external stakeholders.

Qualifications:

• Bachelor’s degree in science (Biological or Life Sciences, Biotechnology or Microbiology), Master’s degree is preferred.
• 5-7 years of experience working in a cGMP environment.
• Broad knowledge and expertise in some or all the following manufacturing areas: Cell Expansion, Cell Culture, final formulation of cell products.
• Solid understanding of Health Canada/US FDA GMP regulations and Quality Assurance principles.
• Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task is essential.
• Drive for results is essential.
• Strong English written and verbal communication skills.
• Strong working knowledge of Microsoft Office programs.
• Proven track record of writing GMP documents (i.e., SOPs, validation procedures).

Desired Characteristics:

• Ability to influence team members and provide constructive feedback via Operations Manager.
• Skilled at troubleshooting and investigating process or equipment issues.
• Understanding key metrics, ability to effectively communicate and report metrics.
• Maintains a continuous review of production demands and ensures manpower is properly assigned on a daily basis to reach the necessary production output.
• Makes recommendations for changes to improve quality and reduce costs.
• Assists Operations Manager in developing initiatives to improve production performance.
• Assist Operations Manager by leading and supporting continuous improvement activities, pertaining to improved safety, quality and/or training.
• Performs other duties as requested, directed, or assigned.

CCRM 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.

CCRM 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.