Trung Trinh Email & Phone Number

Oreland, PA, US

West Point, PA

Batch disposition, Change Control, Deviation Management, Validation.

West Point, Pennsylvania

Batch Record Review, Shopfloor Walkthrough, Deviation Management,

West Point, Pennsylvania

Laboratory Test Record Review, walkthrough audits, Quality Support and contact

West Point, PA

• Served on laboratory cross functional team involved in assay monitoring, development, design and validation of various Vaccine & Biologics projects
• Trained and managed new group members in laboratory techniques, assay procedures and information managing systems according to GMP standards
• Performed high throughput ELISA assay on process intermediates, manufacturing and experimental samples for live virus vaccine
• Conducted research and testing for Biomarker Assay used for routine process monitoring and deviation investigations
• Developed and Executed Plaque Assay in Biosafety Level 2 Laboratory for assay optimization and scale up for pandemic disease
• Authored equipment SOPs and perform Second Scientist Review of Technical Documents, Electronic Laboratory Notebooks and Validation Spreadsheets

• Responsible for process development of mammalian cell purification via quantitation of Protein A ELISA and Host Cell Protein ELISA
• Performed environmental testing of water samples for total organic carbon within cGMP environment
• Ensured Completed documentation for GMP samples and recorded data from daily instrument calibrations
• Participated in investigation and root cause analysis of Out-Of-Specification results upon discovery during cGMP analytical testing

• Performed analytical testing for microbial identifications via LAL testing and Bioburden
• Routinely performed release testing for raw materials and finished products in conformance to USP guidelines
• Reviewed Quality Control data and batch records via SAP system for accuracy and completeness for pharmaceutical products

3701 Welsh Rd, Willow Grove, PA 19090

• Analyzed human clinical and forensic samples for presence of abused and therapeutic drugs by means of ELISA via automated operation of TECAN Liquid Handler & Robotics
• Maintained, calibrated and performed troubleshooting on multiple instruments including TECAN Evo, TECAN 96 PW Microplate Washer, TECAN Infinite Microplate Reader, Olympus AU-400, TDx-FLx, and PLAB
• Prepared and validated reagents, controls, and calibrators for use on multiple assays including Enzyme ImmunoAssay’s EMIT, ELISA and FPIA
• Managed the department as senior analyst on second shift by prioritizing and delegating tests to be completed
• Streamlined and standardized department workflow as LEAN Manufacturing 5s representative by increasing workplace organization and productivity