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 -> Support customers on PAT spectroscopy and HMI/DCS system qualification

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

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

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 manufacturing sites· Tracked the implementation progress of PAT and Quality System and developed/managed program for ongoing education of PAT/QbD projects

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 leaded the scientific discussion with FDA PAT Team on the Barr’s PAT project.· Developed risk assessment/management plans and validation protocols on new PAT related quality system in manufacturing area· Implemented six-sigma concept to reduce the process variation and root-cause analysis

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 cycle time. Identified the requirements of DCS/PLC automation, designed fiber-optic probe configuration and probe clean-up mechanism to improve the quality of spectral data.· Developed and implemented lab spectroscopic methods for raw material/API identity test, moisture determination and content uniformity. Transferred methods to various QO labs worldwide under cGMP compliance. Organized and prepared transfer protocols and supported documents for future NDA/annual Reports.· Developed new technology (near-IR, Raman imaging and acoustic) to explore the homogeneity and sticking of solid dosage forms on the early formulation stages. Pioneered and promoted the use of chemometric methods for image data analysis providing an efficient approach to understand the drug distribution and polymorph characterization.

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 portable Raman and NIR spectroscopic techniques· Applied and improved the process optimization algorithms of blending control systems · Implemented novel chemometric methods to improve prediction accuracy/precision and designed automated protocol for material sorting on an in-line elemental analyzer

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 time· Implemented NIR, microwave sensor & E-Nose and multivariate calibration/discriminant analysis to monitor finished products and raw material identification for better quality control