Patrick Xaphakdy Email & Phone Number

Cottage Grove, Mn, Us

Saint Paul Mn

Greater Minneapolis-St. Paul Area

. Perform method validations, create protocols and writing final protocol reports. . Develop new chemistry formulation for advanced disinfectant products, detergent and cleaning chemicals. . Perform critical analysis of data, interpret results and draw scientific conclusions. . Communicate the results through documentation, trending, statistical process control and ICH guideline. • Perform unknown & contamination identification, molecular fingerprint, functional group identification.• Present data to the R&D chemistry group meeting • Perform formulation evalutation, material compatibility studies and testing of advanced disinfectant polymer and sterilant products. • Perform cleaning recovery study of semi-clinical medical devices based on various soil property around the world and ICH guideline.• Perform endoscope reprocessing and cleaning validation studies. • Perform method development for raw material, stability & finished goods of disinfactants, surface cleaner, and cold sterlization products. • Assist in identifying new projects and specific work area improvement and new product trend.

Greater Minneapolis-St. Paul Area

•Coordinate testing of marketed products, raw materials , stability testing with reduced turnaround time of 50% less than normal pharmaceutical industry standard. •Solve many chromatographic resolution issues of assay, dissolution, impurities testing. As results, greatly help the company from chronic backorder situation to fully met the market need of high demand of ANDA (Abbreviated New Drug Application) products. •Review electronic data as well as notebook peer review regularly.•Performed routine qualitative and quantitative testing competently with nearly eliminated laboratory errors. •Revised SOP, analytical methods to ensure with cGMP, current lab practice and USP-NF conformance. •Coordinate and keep tract of control drug substances and its waste to ensure compliance with DEA.•Certified spilled/cleanup responder for large chemical waste spills and coordinate chemical waste for quality control chemistry lab.•As certified personal to review data and work-related to ANDA products. •Audited current specification, method transfer, method validation, equipment qualification, manufacturing cleaning validation, raw material vendor testing. Participate in preparing documentation, system of quality assurance and compliance for prep-approval Inspection by FDA•Reviewed lab notebook, electronic data, cleaning validation and prepare laboratory colleagues for FDA visit.

Saint Paul-Mn

•Successfully performed various pharmaceutical development studies of mechanical, chemical functions and performance of metered dose drug inhalers.•Successfully involved in 5 major R & D projects for including drug reformulation, early pharmaceutical development, 3rd stage of Clinical trial, toxicology campaign studies for both US and European Union markets.•Executed competently the protocol of extreme condition and patient’s real live situation usage of drug inhalers and stability, usher and non-conformed protocol. Performed analytical testing particle size, through life medication doses, through life uniformity of doses, filled weight, spray testing, drug content, impurities profile, alcohol content, water content and other physical testing of drug canister. •Maintained excellent documentation of technical notebook, record. Serve in the department’s quarterly notebook audit team. Perform notebook peer review regularly. Validate electronic data, Excel spreadsheet, reports to ensure accuracy and traceability of data. •Trained new analysts for routine methods of testing and also provide well-written, accurate and timely reports.•Served as hazardous waste coordinator as well as lab steward for two busy R & D labs.•Investigated OOS, out of trend, suspect results, consumer’s complaint products and write full investigation report concisely

Greater Minneapolis-St. Paul Area

•Lead chemist at Chromatography Technology Center-Westside Research Center•Managed two high volume labs with 5 lab analysts and 2 lab assistants successfully. •Improved extraction techniques for certain food products that have high content of additives and protein. This leads to reduce repeated testing and increase reproducibility results. •Over 7 years, has been assigned and promoted to various positions and responsibility at the corporate Analytical department as research assistant at flavor technology, lab analyst, analytical chemist in protein, vitamin, wet chemistry, pesticide labs and sugar labs. •Served in the quality council for the department, in charge of reducing laboratory errors, and out of trend.

Master Of Arts (M.A.), Leadership

Activities and Societies: Pan-Asian Student Association

Bachelor Of Arts (B.A.), Biology & Chemistry ( Double Majors )