Job Description
Responsibilities
- Prepare instruments and perform cell expansion, cell culture, depth filtration, and other process operations in compliance with GMP requirements.
- Conduct aseptic procedures, including vial thawing.
- Perform environmental monitoring during recovery as authorized by QC.
- Execute cleaning activities in clean areas per GMP standards (periodic, changeover, and equipment cleaning).
- Draft and revise documents such as SOPs, MBRs, URS, FAT, and SAT.
- Participate in investigations, change implementations, deviations, audits, and corrective actions.
- Coordinate and deliver training; maintain accurate and timely training records.
- Oversee daily upstream operations and manage cell bank activities.
- Support tech transfer projects and sample management tasks.
- Manage and maintain equipment, ensuring proper functionality.
- Carry out additional responsibilities as assigned by the direct sup...