GMP Manufacturing Specialist

GMP Manufacturing Specialist

Apex Systems is recruiting 5 GMP Manufacturing Specialists for a biopharma client. Candidates should have a microbiology background with experience in mammalian cell culture, aseptic techniques, and working in BSL‑2 or clean rooms, as well as knowledge of GMP.

Innovative Biopharma Start‑up

18‑month contract/perm

Downtown Toronto

• Follow SOPs for cell manufacturing under cGMP guidelines.
• Operate clean‑room instrumentation (cell separators, counters, etc.).
• Assist technology transfer from R&D to GMP environment.
• Support routine expansion, differentiation of PSCs, and related qualification studies.
• Prepare documentation and reports for Quality Assurance and management.
• Manage inventory and procure raw materials.
• Validate/clean equipment and facility; execute IQ/OQ/PQ protocols and prepare SOPs.
• Participate in cGMP training activities.
• Produce cell drug substance and product for non‑clinical and human clinical trials.
• Coordinate with QA to complete all associated documentation.
• Assist QA/QC with analytical methods and associated documentation.
• Support QA in handling quality events (deviations, CAPAs, OOS, etc.).
• Track equipment records for PM/calibration and clean‑room maintenance.

• BS in Biology, Biochemistry, Engineering, or related field.
• 1–7+ years experience in aseptic techniques and handling mammalian cells.
• Hands‑on experience in human stem cell production (highly desirable).
• Experience with PSC culture and differentiation (highly desirable).
• Experience writing and validating SOPs and protocols (highly desirable).
• Knowledge of Good Documentation Practices (preferred).
• Willingness to work shift hours including evenings, weekends, holidays.
• Strong written and oral communication skills.
• Proficiency in MS Word, Excel, database programs; eQMS/LIMS experience desirable.

Apex Systems is an equal‑opportunity employer and does not discriminate on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, disability, or any other characteristic protected by law.

Salary: $130,000‑$150,000 (Annually)