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Technical Support Quality Control

Location:
Yonkers, New York, United States
Posted:
January 26, 2017

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SAAD SHERWANI ** Hamilton Avenue // Mount Vernon, New York 10552 // 914 *** ****

acyhsp@r.postjobfree.com

Qualifications Summary

Analytical Chemist specializing in automated instrumentation training and troubleshooting on HPLC, UPLC, LC/MS and GC with vast experience as a team leader in method development, stability testing and method transfer.

Professional Experience

Chroma Research Labs Stony Brook NY

Sr. Manager January 2016 - Present

Managed FDA approved Contract Lab. Various testing performed using all instruments. Transferred vendors’ methods and validated methods based on ICH guidelines. Trained college graduates on lab equipment and protocols to assist in workforce entry.

Amneal Pharmaceutical Piscataway NJ

Quality Control Technical Group September 2015-December 2015

Developed and performed routine testing methods for Peel, Adhesion and Shear tests. Performed and organized Dissolution, Assay and Impurity testing to support formulation for trial batches. Improved testing methodologies and efficiency in diverse generic pharmaceutical lab. Utilized instrumentation alternatives for improving testing times and protocols.

LTS - Lohmann Therapy Systems W. Caldwell, NJ

Team Group Leader- Method Transfers May 2012 – May 2015

Analyzed instrumentation process to ensure successful international method transfers of transdermal dosage testing between Germany and the United States ensuring all technology and product compatibilities. Improved laboratory practices maximizing efficiency. Performance monitoring of multiple HPLC, UV, FTIR including basic system administration (Star, LIMS and Empower 3). Performed gap analysis and feasibility studies in receiving laboratories for all equipment and chemicals. Trained analysts on standard procedures according to ICH guidelines and standard operating procedures.

PepsiCo- Contract Employee Valhalla, NY

Natural Product Scientist April 2011 to April 2012

Participated in successful startup of Long Term Research (LTR) bio-analytical laboratory. Utilized Electronic Lab Notebook. Performed extraction and separation of natural products. Operated instruments such as Sepbox 2D, CombiFlash, Torrent, Soxhlet (Buchi B-811), Eft-90 NMR Spectrometer and UPLC H-Class with PDA and ELS Detectors. Developed various assay testing protocols of natural sweeteners on UPLC.

Barr Laboratories (now Teva Pharmaceuticals) Pomona, NY

Senior Chemist 1994- 2010

Received and Implemented Waters’ training on UPLC and HPLC to multiple lab leaders at various sites.

Provided system administration, troubleshooting and technical support to lab scientists on UPLC, HPLC, LC/MS, GC and dissolution systems. Led laboratory equipment qualification, maintenance, and calibration.

Barr Laboratories (cont’d)

Training Team Leader Resolved instrumentation and other laboratory issues in chemists’ daily task completion on UPLC, HPLC, LC/MS and GC.

Customized training module and trained all new hires on instrumentation and respective software.

Applied advanced analytical skills to develop test methods for complex products and performed full method validation analysis of all company products.

Completed calibration/maintenance programs for all automated workstations and all major instruments including HPLC’s, GC’s, Dissolution and UV’s.

Audited and summarized performed efficiency checks of laboratory workbooks from vendors IQ/OQ and PQ Binders.

Upgraded and calibrated several Alliance LC’s to latest version ahead of schedule.

Led training for analysts on BDS, multi-dose G3 +, SDAS and TPW systems.

Developed, finessed and executed process validations for multiple drugs by investigating different potencies using robotic systems.

Upgraded BDS software to Windows for compliance with 21 CFR 11.

Transferred complex methods from HPLC to UPLC.

Participated in implementation of new systems: Totalchrom, Empower, LIMS, UV Winlab, GMPharma and WinBSR.

Performed raw materials, finished products and stability samples testing of all complex products according to regulatory requirements.

Performed dissolution testing in Batch Dissolution System (BDS), assay testing and content uniformity on tablet processing work (TPW) stations.

Hi-Tech Pharmacal Amityville, NY Stability Supervisor 1992-1994

Managed quality control laboratory consisting of twelve chemists. Interfaced with Planning, Production, Technical Support and Analytical Research to facilitate production, special projects, process validation samples and transfer of methods from R&D Department. Provided final approval and release for raw materials, in-process and finished products. Assured compliance of lab operations including safety protocols.

Abbott Laboratories Karachi, Pakistan

Scientist 1991-1992

Performed qualitative and quantitative testing of raw materials, finished products and stability samples on HPLC, GC, FT-IR, NIR, Karl Fisher, UV/VIS spectrophotometers and other equipment. Products included consumer products and prescription drugs.

Technical and Scientific Training

Zymark Corporation, Hopkinton, Massachusetts. Completed courses on BDS, TPW & Multidose G3+.

Waters Corporation, Morristown, New Jersey. Received troubleshooting training on UPLCs.

Education

1988-1990 Queen Mary College, University of London, England

Post Graduate Research in instrumentation methods and chemical research.

1987 Bachelors of Science in Chemistry, Karachi University, Pakistan



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