- Read and follow established SOP’s, document activities and information using GDP
- Adhere to gowning procedures required to work in cleanroom environment
- Review inventory and maintain adequate supplies in GMP stock room, clean, and stage materials for delivery into cleanrooms
- Follow BPR to prepare buffer and media as well as manage collection and disposal of solid/ liquid waste from manufacturing
- Manufacture gene and cell therapy products for use in clinical setting
- Use proper aseptic techniques to ensure sterility of gene and cell therapy products
Perform manufacturing process in a sanitized laboratory setting with routine use of:
- Biological Safety Cabinets (BSC),
- Incubators,
- Micropipettes (P200-P1000),
- NC-200,
- Climet,
- Surface Air System (SAS),
- Controlled Rate Freezer (CRF),
- Environment and Personal Monitoring to ensure sterility and no growth of microorganisms.