Provide analytical and wet chemistry support for new product development used for 505 (b) (2) pipeline. Pipeline includes the successful launch of three new FDA approved/commercial products, and two new products in late-stage development.Develop UPLC/HPLC assays for newly formulated products and their related impurities and degradants which are successfully transferred and validated at outsourced CROs/CDMOs.Assist with formulation development and optimization of oral and suspension products which includes conducting stability programs for these products and clinical trial feasibility.Co-Inventor on multiple patents for oral liquid formulations as well as provided IP/prosecution support work for numerous other applications. Manage laboratory operations including instrumentation, inventory, and waste disposal.Review and audit outsourced CROs/CDMOs to ensure GLP/cGMP compliance with validation processes, protocols, and reports for multiple products.

Developed and validated stability-indicating HPLC methods for multiple API drugsResponsible for QC control release testing of raw materials, production intermediates, and finished products using HPLC, GC, FTIR, Karl Fischer, and other wet chemistry techniques.Liaise with customers, production chemists, project managers, and other QC chemists to assist with the development and production of API drugs from bench to market.Other responsibilities include staff training, SOP creation and revision, equipment troubleshooting including HPLC and GC instruments, and writing technical reports to document analytical method validations.

Provided analytical support to Quality Control for raw materials and finished product testing.Managed multiple remediation projects directed toward meeting FDA/GMP complianceDeveloped HPLC assays for complex mixtures and their related impurities and degradantsValidated HPLC methods for finished products under FDA/ICH/USP guidelines.Wrote reports and updates as needed by Quality Control management team.Reviewed and audited outsourced CROs to ensure GLP/cGMP compliance.

Provided analytical support to Product R&D programs.Lead chromatographer on multiple in-house newly formulated oral liquid/solid and inhalation products.Developed multiple novel HPLC assays for company's main technology, Captisol®.Developed multiple HPLC assays for complex mixtures and their related impurities and degradants. Conducted stability programs of newly formulated drugs for product and clinical trial feasibility.Assisted with intellectual property development and applications of newly formulated products.Responsible for instrument maintenance, staff training, and HPLC troubleshooting.Wrote reports and updates as needed by R&D management team.Reviewed and audited outsourced CROs to ensure GLP/cGMP compliance.Supported ANDA, NCE/IND, and patent applications to the FDA.

Provided analytical support for new formulated drugs being developed at NexMed.Helped install, implement, and qualify Perkin Elmer HPLC systems with TurbochromTM Data System.Performed HPLC sample prep, HPLC analysis, protocol and report writing, and data processing.Trained new employees in HPLC, sample prep, data processing and wet laboratory techniques.Maintained and calibrated Perkin-Elmer Series 200 HPLC systems.

Provided analytical and formulation support following GLP/cGMP guidelines.Validated HPLC methods for drugs and related substances under FDA/ICH/USP guidelines.Conducted in-process and finished product testing including pH, colorimetric analysis, Karl Fischer.Maintained & calibrated HPLC instruments including Hitachi, Agilent, and Perkin-Elmer systems.Trained new staff on laboratory techniques and PE Nelson TurbochromTM Data System.Evaluated notebooks and projects under GLP/cGMP guidelines.

Developed sample handling, preparation, and analytical methodologies for pesticide studies.Operated, maintained, and provided training on multiple laboratory instruments.Responsible for HPLC, GC, atomic absorption, spectrophotometers, and water quality testers.Assisted with the development of environmental field and writing skills for graduating seniors.Coordinated and conducted ecological field studies.Published research on the use of outdoor microcosms for studying environmental contaminants.

1997-1998, 2002Provided chemistry and analytical support to pharmacology, toxicology, and environmental R&D programs following GLP/cGMP guidelines.Prepared Dioxin/Furan and PCB standards and samples analyzed for GC/MS under EPA/TSCA.Assisted with data interpretation and processing of dioxin, furan, PCB GC/MS analysis.Developed HPLC assays with radiolabeled compounds for metabolism and bioavailability studies.Lead analyst for characterization of malathion residues in animal studies.Developed sampling protocols and analytical methods for TNT explosives by GC/ECD.Assisted with method development, protocol and report writing, data handling, and staff training.Maintained laboratory equipment, including four HPLC systems.Performed method development, sample preparation, and HPLC analysis.Evaluated pharmaceutical stability samples and conducted purity analysis.Served as chromatography troubleshooter in GC and HPLC.Analyzed organophosphorus pesticides by GC/FPC under EPA/FIFRA.