
Cell Culture
2 weeks ago
As a Lead Engineer, you will play a crucial role in the timely and successful transfer of customer manufacturing processes into our production facility.
- Prepare, execute, monitor, and manage process activities for cell culture or purification stages of customer manufacturing processes at our Singapore production facility.
- Develop expertise in all processes within the facility and drive ability to support/lead activities across multiple processes.
- Regularly monitor processes to identify trends and detect potential process issues. Develop ability to generalize issues across processes.
- Investigate process deviations involving multiple departments and customers, write change requests, and drive implementation.
- Review cell culture or purification process manufacturing batch records and provide technical input to MFG technical document writing specialists.
- Identify training needs and provide materials for MFG operators on cell culture or purification process batch records.
- Collaborate with MFG to update process batch records and enable robust manufacturing operations.
- Support start-up, pilot/commercial runs, perform technical investigations, and help author reports to close-out deviations.
- Prepare Annual Product Review (APR) and Continued Process Verification (CPV) summary reports and support work-stages for customer BLA filing.
- Maintain process databases, ensure batch-to-batch consistency, and support inspections and audits by customers and regulatory authorities.
Our ideal candidate should have over 5+ years of experience in biotechnology process development, process support, research, or a related manufacturing environment.
- Graduate degree in Chemical engineering, biochemical engineering, biochemistry/chemistry/biological science, or a related field.
- Prior experience in technology transfer in the purification or cell culture domain.
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