- Hamilton, Ontario, Canada
- Contract · Associate
- 4+ years
Responsible for quality control activities for GMP manufacturing of cell and gene therapy products, including testing, sample management, equipment qualification, method development, data review, and audit participation.
Compensation
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.
Responsibilities
- Delivers quality control-related services including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management
- Collaborates with Production, MSAT, and QA teams in preparation of master batch record, sampling plans, and specifications
- Maintains the materials specification program
- Releases materials
- Manages the retain and references standard program
Requirements
- Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.)
- Nice to have: Master’s degree
- Nice to have: ISO
- Nice to have: Regulatory frameworks