Deadline-driven Analytical Chemist demonstrating superior quality assurance and accuracy in recording results. Astute professional with exceptional usage of analytical techniques, including thin layer chromatography and high pressure liquid chromatography. Ready to join a new organization collaborating with other professionals in a laboratory environment.
Overview
13
13
years of professional experience
Work History
Analytical Chemist
ALMAC Group
10.2023 - Current
Execution of development, validation, transfer and release testing of non-GMP and GMP projects.
Senior Research Scientist
Douglas Pharmaceuticals
03.2022 - 07.2022
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.
QC Chemist
Medical Products Laboratories (MPL)
10.2020 - 03.2022
Analysis of raw materials, finished products and stability samples by HPLC/UV and other lab techniques
Analytical 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.) Utilize GC/Headspace analysis to develop and validate residual solvent methods for API’s and finished products
Utilize Empower 3 for quantitation of analysis.
Chemist A
Aurobindo Pharma USA
01.2017 - 10.2020
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
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.
R&D Scientist III
Lannett Co.
02.2014 - 12.2016
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: Independently planned and executed testing to meet established deadlines
Performed peer review of data and results.
Contract Scientist
Purdue Pharma
08.2013 - 02.2014
Characterize solid dosage dissolution profiles using fully automatic instrumentation interfaced with HPLC systems
Perform HPLC analysis on stability samples of controlled substance dosage forms for assay and impurities
Validate HPLC/UV methods to ensure compliance with ICH guidelines for impurities in finished products.
Associate Scientist
CorePharma LLC
06.2012 - 05.2013
Support new product development for generic solid dose pharmaceuticals
Develop HPLC/UV analytical methods for assay and impurity testing
Perform assay and impurity testing on controlled substance finished products for stability studies and product development samples for content uniformity
Perform dissolution testing for extended-release tablets and capsules.