Production Scientist - Torrance

The Production Scientist is responsible for upscaling R&D small scale work into GMP large scale manufacturing, overseeing production activities, collecting and analyzing GMP data, and driving yield and process improvement projects.

Requirements

• Review and approve quality and validation documents
• Perform Operational assessments
• Prepare weekly slide deck presentations on project updates
• Lead and/or prepare and/or support product investigations
• Author, prepare and support Deviations, process change controls, CAPA
• Prepare Change Control Change Request and list of change document
• Draft and review Standard Operating Procedures
• Conduct Risk Assessment
• Approve quality documents
• Generate detailed Gannt chart of batch schedule
• BOM generation and Process mapping
• Provide on-floor and remote 24/7 technical support
• Project management of operation activities
• Draft, format and improve MBPR template
• Support technology transfer activities
• Author and review campaign reports
• Raw material OOS assessment
• Conduct Bottle neck analysis and Gap analysis of unit operations
• Prepare Process capability analysis
• Conduct cost analysis and forecasting
• Liaise with cross functional groups
• Collaborate with PD to Design small scale experiments
• Lead, mentor and train Operators and team members
• Support continuous improvement initiatives
• Manually Collect, trend, and analyze in process data
• Support QA and regulatory with responding to comments by clients
• Support Validation activities during the planning execution of PPQ runs
• Support regulatory review of documents
• Process Mapping
• Routes and Formula on AX