More than ••••• years of experience in analytical chemistry, with four years exclusively in pharmaceutical laboratories. Plus worked with ICP-OES and ICP MS extensively by using Perkin Elmer (ELAN DRC-e) and Leeman Labs (Prodigy High Dispersion).
Highly skilled in state of the art instruments inclu••••• but not limit to HPLC (HP•••••, LC•••••), GC (•••••, MS•••••, Headspace •••••C, etc), ICP-MS, ICP-OES, Cold-Vapor Atomic Fluorescence, Spectrum One, UV/VIS, Atomic, FTIR, Beckman Coulter particle counter, and etc. Ability to perform routine calibration, maintenance and troubleshooting.
As stability coordinator, analysis stability products, accor••••• to ICH guidance and our specifications, release results to customer.
Performed method development, validation and transfer. Generated reports and wrote SOPs.
Ability to interpret HPLC, GC and UV/VIS results. Participated in OOS and OOT investigations.
Function as raw material team leader, make plan and arrange samples, tested and validated data in the LIMS and monitored production by using SAP system. All were under USP and ANSI guidance.
Fluent with data capturing software for HPLC and GC such as Millennium, ChemStation and Empower.
Experienced with GMP, FDA, and ISO ••••• guidelines.
BS Chemistry, Kutztown University, Kutztown, PA •••••
Renewable Silicon International, Inc. Easton, PA Sept. ••••• Dec. •••••
Worked as a contract employee until the company experienced a set back on production equipment.
? Performed routine testing using ICP-OES (Leeman lab, Inc) analysis, developed methods for multi-elements analysis. Analyzed products from raw material, in-process and finished products. Prepared standard chemical solutions accor••••• to SOPs and generated laboratory reports following industry standards.
? Developed new SOPs for daily standard weight calibration and pipe calibration, etc.
G&W Laboratories, Inc. South Plainfield, NJ May, ••••• Sept. •••••
? Performed routine testing on drug substances using HPLC, GC, UV/VIS, IR, KF, and all general lab techniques inclu••••• dissolution as well.
? Performed testing on raw materials, in processed and finished products, analyzed, evaluated data and reported results.
? Company is undergoing reconstruction, I was laid off.
Hawk Mountain Labs Inc. West Hazleton, PA Oct. ••••• May. •••••
Metals Chemist •••••
? Performed trace metal analysis on environmental samples such as water, soil and coal for independent clients. Manage daily routine of sample preparations, analytical testing, and result reporting base on guidelines specified by EPA, ASTM, and in house quality control standards.
? Working with instruments such as: ICP-MS (Perkin Elmer ICP MS ELAN DRC-e), ICP-OES (Prodigy High Dispersion, Leeman Labs), and Cold-Vapor Atomic Fluorescence (Leeman Labs).
? Revised the ICP-MS operation instruction SOP for better clarity.
Researched, developed, validated the test method of the cold vapor atomic fluorescence (Leeman Labs) and generated the new SOP from ground zero.
Lonza Inc., Conshohocken, PA••••• Mar ••••• Jan •••••
Performed routine testing on API drug substances using HPLC, GC, UV/VIS, FTIR, KF, and all general lab techniques. Evaluated data and reported results.
As stability coordinator, wrote protocol, monitor chambers, accor••••• to ICH, investigation about OOS & OOT, reported to senior chemists & QA.
As raw material team leader, arranged priority in the lab. Assigned personnel to perform key chemical analysis functions. Coordinator QC, samples area and production
Coordinated stability studies and data release as per ICH guidance and in-house QC specifications.
Calibrated and maintained all instruments in good working conditions.
Ensured all analyses conducted based on cGMP and following FDA guidelines.
ConAgra Foods Inc., Easton, PA••••• Apr ••••• Mar •••••
QA/QC Technician II
Analyzed starch raw materials, in-processed and finished products by using food industry specialized instruments such as Farinograph, Foss, Ash Oven, Muffle Furnace and Mixograph.
Performed, implemented, audited and validated analytical test methods, procedures for QC lab and production process.
PPT Research, Inc., Allentown, PA••••• Oct. ••••• Apr •••••
Senior R&D Laboratory Technician •••••
Performed routine QC analysis on raw materials, in-processed samples, and finished products (polymer and water base silicon carbide slurries) using Water GPC, Hewlett Packard GC, Perkin Elmer ICP-AES and AA, UV/VIS, Brookfield viscometer, Brinkman auto titrator, Coulter particle counter and Fisher Scientific tensiometer and all other ASTM and general wet chemistry techniques. Reviewed and released QC data adhering to GMP and ISO standards.
Research and development for new products. Co-author of a US patent on the polymer emulsion solution used in the chemical and pharmaceutical industries as a suspension carrier.
Developed, implemented and validated new analytical testing methods.
Performed routine safety inspection and trainings.