Su-Chin Lo Email & Phone Number

Irvine, CA, US

1.Develop customer designed PAT hardware/software for supporting smart manufacturing (Pharma 4.0) and continuous manufacturing process 2. Support clients/customer for the method development, implementation and GMP related strategy on process analytic project3.Review and train customers on computer system validation (CSV) strategy and protocol/documentation.

• PAT, QbD and qualification (GAMP 5) project support for pharmaceutical & biopharmaceutical clients
• Supported and trained CMO client for PAT method development and analytical method validation. PAT project -> audited & approved by the European sponsors
• Performed gap analysis of manufacturing process-> identified root causes of abnormal hydrogenation unit operations
• Supported clients to identify CMAs and CQAs and implemented process monitoring strategy-> and improved drying time from 120 hours to 70 hours

Brentford, Middlesex, GB

• Developed PAT Infrastructure, coordinated with GSK R&D Teams (UK &USA, and managed/implemented PAT projects in GSK State-of-Art R&D Pilot Plant.
• Identified, designed and commissioned PAT analytical toolbox for various unit operations within six (6) months.
• Closely monitored and trouble shoot PAT equipment to archive their consistent operation (total of 72 batches)
• Improved the API form conversion process time by at least 50% based on on-line PAT monitoring

Rahway, New Jersey, US

Responsible for providing strategic direction, development, and technical leadership on S-P PAT and process improvement projects. Provided technical expertise to support “Quality by Design” in new product development. KEY ACCOMPLISHMENTS: · Leaded and trained PAT Team members (multidisciplinary) to understand & implement PAT projects in SP Global.

Designed, implemented and managed Process Analytical Technology (PAT) projects to improve process consistency on existing commercial products. KEY ACCOMPLISHMENTS:· Designed and implemented PAT measurement tools (hardware/software) to optimize the blending process for reducing failure rates· Prepared and submitted PAT Comparability Protocol to FDA and.

Rahway, New Jersey, US

Provided technical supports/training to worldwide analytical & quality control labs and served actively on numerous spectroscopic-based method developments. KEY ACCOMPLISHMENTS:· Implemented and maintained in-line near-IR chemical analyzer for the monitoring of drying/media milling/crystallization processes resulting in >50% reduction in product analysis.

Waltham, MA, US

GAMMA-METRICS Division/San Diego, CAManaged chemometric activities of the new neutron activation analyzer and Raman spectroscopy projects. Built the calibration transfer protocols enabling cost reduction for the development of new analyzer.KEY ACCOMPLISHMENTS:· Developed novel algorithms to identify major component from illicit drug based on the use of a.

US

United States Tobacco Manufacturing Company, Nashville, TNKEY ACCOMPLISHMENTS:· Constructed early diagnosis methods (neural networks) based on the optical spectroscopy and Electronic Nose to reduce process mis-operations in the production line · Developed protocols for calibration model transfer and instrument standardization to reduce model re-developing.