M.S. Chemist Utilizing Analytical Equipment in Legal Investigations in the areas of: HPLC, UPLC, Calibration

Technical Consultant #2579

• X HPLC (High Performance Liquid Chromatography and UPLC (Ultra Performance Liquid Chromatography).
Assay and impurity analysis for APIs and finished products.
Method development and validation.
KF titration for water content.
GC (Gas Chromatography) with FID (Flame-Ionization Detection), ECD, TCD, NPD for residue detection.
GC/Headspace with FID for volatiles.
cGMP (Current Good Manufacturing Practices) compliance.
Lab Investigations and reports.
Safety practices in the lab
Controlled substance handling and disposal as per DEA guidelines
Sample preparation for extended-release tablets
Dissolution testing of tablets to meet USP specifications.
Peak purity testing using photodiode array detection in chromatography.
Stability testing of excipients, active ingredients and finished products.
Fatty acid ratio determination in olive oil samples using HPLC to check for adulteration.

Expert Witness Experience

(Patent Infringement), Provided scientific data for a patent infringement case regarding acetic acid synthesis.
Client claimed that a competitor was using his patented synthetic route as a way to get very pure acetic acid without impurities. Commonly use synthetic pathways to make acetic result in known impurities in the final product.
Installed a GC with headspace and an FID detector with the proper column to analyze impurities in acetic acid. Being provided with the known impurities that arose in more common synthetic paths and a sample of the batch suspected of using the patented process synthesis without prior authorization.
The standards that are known to be in commonly used synthetic paths for acetic acid were not found in the sample. This confirmed that the competitor was using the patented synthetic path without authorization.

D. P. Company, Senior Research Scientist, 2022 - 2022

Support of product development for oral suspension.
Analysis of raw materials, finished products and stability samples by UPLC/UPLC with UV or RI detection.
Particle size analysis of suspensions using Mastersizer 3000.
Density determination of suspensions.

M.P.L, Philadelphia, Pennsylvania, QC Chemist, 2020 - 2022

Analysis of raw materials, finished products and stability samples by HPLC/UV and other lab techniques.
Analytical Method Development and Method Validation as per regulatory guidance (ICH, FDA, USP, BP, EP etc.) for new formulations including but not limited to Tablets, Capsules, Gels, Pastes, Creams and Oral solutions/Suspensions.
Review of analytical data.
Perform method transfer activity with various customers.
Perform various analytical tests to ensure product meets all specifications.
Calibration of various analytical instruments (HPLC, Spectrophotometer, dissolution apparatus etc.)

Aurobindo Pharma USA, Dayton, New Jersey, Chemist A, 2017 - 2020

Develop and validate test procedures.
Perform routine and non-routine physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques including UPLC and HPLC.
Utilize GC/Headspace analysis to develop and validate residual solvent methods for API's and finished products.
Diagnose LCs including Waters UPLC Acquity H-Class, Waters HPLC Alliance e2695 with UV 2489 or PDA 2998 detectors and Shimadzu LC10AD HPLC for performance issues like faulty check valves and malfunctioning Gradient Proportioning Valves.
Perform repairs and calibrate LC instruments for parameters including flow accuracy, gradient accuracy, wavelength accuracy, drift and noise and thermal calibration of the column oven.
Document calibrations to reflect PASS or FAIL for each parameter in reference to the performance criteria stated in the current SOP.
Maintain PM and calibration records for all LCs in the group.
Document instrument observations and initiate CAPA in laboratory activities to prevent instrument downtime.
Performed troubleshooting, repairs and calibration and investigations.

Lannett Co., Philadelphia, Pennsylvania, R&D Scientist III, 2014 - 2016

Evaluate, develop and validate test procedures.
Perform routine and non-routine physical and chemical tests and assays on raw materials, active pharmaceutical ingredients, in-process and finished products, using various wet chemical, physical and instrumental techniques including UPLC and HPLC.

Accomplishments