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Laboratory Technician
2 months ago
- Execute and verify all tasks associated with the manufacture of commercial products in accordance with batch records and standard operating procedures (SOPs).
- Collaborate closely with Materials Management, Quality Control, and Quality Assurance teams to ensure GMP runs are executed efficiently.
- Troubleshoot and resolve processing and equipment issues, communicating updates and concerns to management.
- Complete required training assignments to maintain technical proficiency and ensure compliance with cGMP (current Good Manufacturing Practices) regulations.
- Author and revise SOPs that are clear, aligned with cGMP requirements, and support efficient manufacturing operations.
- Operate sophisticated automated cell processing, cell expansion, and filling equipment in Grade B/C clean rooms.
- Ensure compliance with all PPE and gowning requirements for classified GMP manufacturing areas.
- Identify opportunities to improve manufacturing efficiencies and compliance, and assist with investigations, deviations, and change controls.
- Bachelor’s Degree (BA/BS) in a scientific field
OR - Associate’s Degree (AA) with 1+ year of cGMP experience
OR - High School Diploma with 2+ years of cGMP experience
- Strong understanding of cell therapy manufacturing processes and cGMP requirements.
- Experience operating and troubleshooting cell therapy equipment in a GMP environment.
- Demonstrated ability to follow complex procedures and maintain a focus on compliance and safety.
