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Operations Associate I

4 months ago

toronto, Canada CCRM 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-based 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.


Position Summary:

As an Operations Associate I at CCRM, you will be part of a diverse manufacturing team focused on Good Manufacturing Practices (GMP) production projects for CCRM's GMP facility. This position is required to work on-site to carry out the manufacturing activities in CCRM's GMP facility and process development lab. You will work with the team to execute defined project tasks. This role is required to work in shifts, including weekends. You will support CCRM's mission to bring new and innovative products to market.


Responsibilities:

  • Follow CCRM's policies, standard operating procedures (SOPs), GMP, and Good Documentation Practices requirements.
  • Assist in writing and revising SOPs and master batch records describing operations of equipment and process.
  • Responsible for cleaning, and documentation of equipment in cleanroom for use.
  • Responsible to support process validation, process optimization and process development as required.
  • Assist in the execution of the production batch records or other GMP documents. Ensure that the Grade A and B manufacturing areas are clean and remain in a state of control.
  • Follow CCRM's safety procedures and use personal protective equipment, as required.
  • Other process related tasks that may be assigned.
  • Able to lift or carry up to 20 pounds.


Qualifications:

  • Bioreactor experience required.
  • Upstream Downstream experience required.
  • Bioprocess experience will be an asset.
  • Diploma or higher in biological or life science, pharmaceutical manufacturing, or a related field.
  • Minimum five years of professional experience in Canada, including two years of GMP experience.
  • Strong English written and verbal communication skills.


Desired Characteristics:

  • Experience working in an aseptic manufacturing area.
  • Work experience in cell and tissue culture.
  • Bioreactor experience.
  • Knowledge of Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance principles.
  • Knowledge of the Workplace Hazardous Materials Information System (WHMIS).
  • Ability to work in team environments.
  • Working knowledge of Microsoft Office.


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.

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.


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.


Revision Number: CCRMOAI-20240426