CCRM

www.ccrm.ca

1 Job

203 Employees

About the Company

Regenerative Medicine (RM), which aims to harness the power of stem cells, biomaterials and molecules to repair, regenerate or replace diseased cells, tissues and organs, has the promise to treat, manage and perhaps cure some of the most devastating and costly diseases in the world today. Many new and potentially life-changing RM-based treatments never reach patients because they are not successfully moved from the laboratory to a stage where they can be used in medicine. In order to fulfill RM’s promise to treat the many diseases affecting our population, a world-renowned group of stem cell scientists and engineers have come together to form CCRM, a leader in developing and commercializing regenerative medicine and cell therapy technologies. CCRM formally launched on June 14, 2011. CCRM supports the development and commercialization of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy.

Listed Jobs

Company Name: CCRM
Job Title: Operations Associate I
Job Description: **Job Title:** Operations Associate I **Role Summary:** Supports GMP manufacturing operations in a cell and gene therapy facility, focusing on SOP creation, equipment maintenance, process validation, batch record documentation, and cross‑functional collaboration with Quality Control, QA, and logistics. **Expectations:** Produce accurate, user‑friendly GMP documentation; maintain cleanroom control; execute process validation and optimization; collaborate on project transfers; comply with health‑tech regulations; demonstrate strong communication and regulatory knowledge. **Key Responsibilities:** - Draft and update SOPs, master batch records, and validation procedures from equipment manuals. - Clean, maintain, and document cleanroom equipment (Grade A/B). - Perform process validation, optimization, and development tasks. - Complete batch records, logbooks, and forms under GMP. - Ensure GMP and GDP compliance in all documentation. - Operate pilot‑scale bioprocessing equipment and interact with cross‑functional teams. - Support safety, training, gowning, material movement, and scheduling. - Transfer new projects into GMP with Process Development and Manufacturing Sciences. - Monitor and control operations from an employee safety perspective. **Required Skills:** - Proficiency in English written and verbal communication. - Experience writing GMP documents (SOPs, validation procedures). - Hands‑on GMP manufacturing/biopharma experience (1+ year). - Knowledge of aseptic processing in Grade A/B environments. - Cell culture, immune‑cell isolation/expansion, and bioprocessing fundamentals. - Understanding of Health Canada/FDA GMP regulations and QA principles. - Detail‑oriented, able to translate complex processes into clear text. - Proficient with Microsoft Office; basic familiarity with enterprise quality management software. **Required Education & Certifications:** - BSc in Biological Sciences, Biotechnology, Microbiology, or equivalent industry experience. - Legal eligibility to work in Canada.