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Scientist - Process Validation Scientist
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- Immediate need for a talented Scientist - Process Validation Scientist.
- Key Responsibilities: Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of large molecule biologics Lead Process Validation (Stage 3) activities including: Process validation strategies.
- Timely generation of Chemistry Manufacturing and Controls (CMC) documentation.
- Regulatory and Quality provides statistical support for product monitoring using techniques including statistical process control, process capability analysis, non-linear and linear regression and significant tests.
- Communicate CPV trends to Quality Management and CMC teams.
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