ANTHONY YUAN

Kennett Square, PA ***** acxrwu@r.postjobfree.com 732-***-****

CAREER SUMMARY

Deviation Investigator

Process Engineer

Vaccine/Biologics

cGMP

Experienced Deviation Management Investigator and Process Engineer for lean manufacturing of vaccines and biologics. ~8 years experience with mammalian cell culture, fermentation, and initial clarification unit operations. Proven track record of meticulously conducting thorough investigation of vaccine manufacturing deviations and closure of assignments in adherence to cGMP standards. Provided definitive value to the company through closure of investigations, necessary for release of product to market and supporting company’s continuous process improvement initiatives.

Professional Experience

COMPANY, Merck & Co.

Deviation Management: Lead Investigator Sep 2009 – Apr 2014

Investigated deviations from SOP and Product License which occur during Vaccine Manufacturing through thorough process knowledge and root cause analysis. Assessed and documented product disposition and developed corrective and preventative actions to reduce/eliminate re-occurrence of deviation in alignment with company’s quality management objectives. Collaborated with Operations, Technology, and Quality groups to drive closure of investigations in a timely fashion.

Drove closure of GMP investigations for deviations associated with root causes spanning various aspects of vaccine manufacturing (Batch Documentation Errors, Cell Culture Leaks and Cracks, Out of Calibration Process Equipment, Clean Room dP Excursions, Environmental Monitoring Action Level, HEPA filter failures, Reference Standard Deviations, etc.)

Performed closure of investigations working collaboratively cross-functionally with multiple teams, supporting Varicella (Bldg. 12 and Bldg. 62) and Rotateq Bulk Operations as well as Varicella Downstream Pooling operations.

Developed, tracked, and implemented effective CAPAs to reduce/eliminate the reoccurrence of deviations, resulting in a significant cost savings to the company.

Collaborated with Production Operators to determine causes of human error deviations and develop effective CAPA’s, to drive investigations to closure, in alignment with company quality objectives.

Vaccine Manufacturing Operations Analyst Jan 2009 – Sep 2009

Supported vaccine production floor through lean initiatives to reduce process delays and streamline manufacturing operations.

Designed and implemented a system for management of portable equipment for department 245 Varicella Bulk Manufacturing Process utilizing Lean Six Sigma Tools to reduce process delays and streamline manufacturing operations

Drove the closure of investigations associated to Vaccine – Upstream Bulk Manufacturing through the closure of investigations, to reduce supply constraints to market

External Manufacturing: Process Engineer Apr 2008 – Jan 2009

Supported technology transfer of in-house production functions to external manufacturers as part of company cost saving initiatives.

Supported scale up of Pneumoconjugate Vaccine trials through collaboration with internal Merck Research teams to identify and track key metrics vital to Phase I Trials.

Reduced culture media filtration utilized for 10,000 L production scale up of vaccine production for external manufacturer.

Sterile Processing Technology: Process Engineer Jul 2007 – Apr 2008

Improved inspection systems for Vaccine Filling Operations as process improvement engineer for Sterile Processing and Technology Team. Supported the release of supply to market by driving the closure of investigations as a Deviation Investigator.

Calculated and Updated process capability limits (PCLs) for vial inspection lines using acceptable statistical practices to analyze historical process performance, minimizing reject of acceptable, saleable material and reducing generation of non-value added deviation investigations.

Calibrated inspection machines for liquid filled and lyophilized products to minimize false rejects while maximizing sensitivity of instrumentation to detect and remove true defective products from release.

Supported supply and compliance needs through authoring investigations which reflect adherence to cGMP guidelines and operational excellence.

COMPANY, Ethicon, Johnson & Johnson Sep 2006 –Jan 2007

Laboratory Co-op

Successfully maintained experimental cell cultures for lab research experiments.

Designed and performed various cell culture assays (Cell Count, ATP Detection Assay, DNA/RNA Assays) for support of experimental research of reconstruction of kidney tissue damaged by cystic kidney fibrosis

Shadowed laboratory operations with key research leads to learn fundamental aspects of cell culture and experimental design in research and development

Technical Proficiencies

MS Word / Excel / Powerpoint / Access

Minitab SAP / Lean Six Sigma / LIMS / Green Belt Training

Cell Culturing / Aseptic Technique / Clean Room Gowning / Material Transfer

Education

B.S., Biomedical Engineering, Rutgers University, New Brunswick, NJ

3.4 GPA, High Honors

Minor, Chemistry, Rutgers University, New Brunswick, NJ

Tau Beat Pi (Engineering Honor Society)

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