Harry Singh
Manager Analytical Development at ADMA Biologics, Inc.- Claim this Profile
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Bio
Experience
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ADMA Biologics, Inc.
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United States
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Biotechnology Research
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100 - 200 Employee
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Manager Analytical Development
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Apr 2020 - Present
Boca Raton, Florida, United States
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Senior Scientist
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Apr 2019 - Apr 2020
Boca Raton
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BPC Plasma, Inc.
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Analytical Development Scientist II
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Oct 2016 - Apr 2019
Boca Raton, Florida
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ABL Inc.
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United States
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Biotechnology
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100 - 200 Employee
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QC Analyst II
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2013 - 2015
Rockville Maryland
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Quality Control Analyst
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Jan 2011 - Jan 2012
Developed a reverse-phase UPLC method to determine potential modification to Ad vector proteome component proteins for release testing. Run HPLC & UPLC ion-exchange assays to ascertain particle unit concentration for adenovectors (Ad5, Ad28) Authored change control and lead effort to convert Agilent Chemstation software and methods to Waters Empower 2 and qualify software for cGMP use. Utilized the Malvern Zetasizer and Nanosight LM10 particle sizing instruments to determine… Show more Developed a reverse-phase UPLC method to determine potential modification to Ad vector proteome component proteins for release testing. Run HPLC & UPLC ion-exchange assays to ascertain particle unit concentration for adenovectors (Ad5, Ad28) Authored change control and lead effort to convert Agilent Chemstation software and methods to Waters Empower 2 and qualify software for cGMP use. Utilized the Malvern Zetasizer and Nanosight LM10 particle sizing instruments to determine adenovector aggregation to support PD downstream manufacturing. Perform pH and conductivity tests, pack HPLC analytical columns with various resins for development work, conduct OSS investigation and initiate CAPAs. Show less
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Research Chemist
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Jan 2008 - Jan 2010
Validated chromatographic methods for small molecule and polypeptide compounds for the Agilent 1100/1200 HPLC. Completed full, partial, and stability-only validations of formulations samples according to cGMP, cGLP guidelines. Quantitated metals (anion/cation) concentration via conductivity and amphoteric detection using the Dionex DX-500 Ion Chromatography Systems Authored analytical methods, SOP's, utilize 21 CFR Part 11- LIMS and chromatographic software Empower 2… Show more Validated chromatographic methods for small molecule and polypeptide compounds for the Agilent 1100/1200 HPLC. Completed full, partial, and stability-only validations of formulations samples according to cGMP, cGLP guidelines. Quantitated metals (anion/cation) concentration via conductivity and amphoteric detection using the Dionex DX-500 Ion Chromatography Systems Authored analytical methods, SOP's, utilize 21 CFR Part 11- LIMS and chromatographic software Empower 2 and PeakNet. Show less
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Walter Reed Army Institute of Research
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Research Services
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400 - 500 Employee
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Research Assistant
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Jan 2003 - Jan 2006
Investigated extraction methods for novel drug substances from Lagomorphs and Guinea Pig tissues for LC-MS analysis. Utilized, maintained and troubleshoot the Waters Micromass ZQ Mass Detector to quantitate oximes and various metabolites with MassLynx Ver. 4. Performed radioactive treatments to nonhuman primate specimens (blood and tissue) and human plasma to support preclinical FDA Alzheimer’s disease study. Designed and execute in-vivo small animal trials assessing… Show more Investigated extraction methods for novel drug substances from Lagomorphs and Guinea Pig tissues for LC-MS analysis. Utilized, maintained and troubleshoot the Waters Micromass ZQ Mass Detector to quantitate oximes and various metabolites with MassLynx Ver. 4. Performed radioactive treatments to nonhuman primate specimens (blood and tissue) and human plasma to support preclinical FDA Alzheimer’s disease study. Designed and execute in-vivo small animal trials assessing prophylactic remedies to organophosphate exposure. Performed Neuronal N2A and NS26 cell subculturing and counting with hemocytometer. Show less
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Research Assistant
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Jan 2002 - Jan 2003
Harmonized disparate moisture determining methods for global standardizing initiative. Utilized Orion Karl Fischer Turbo2 Titrators, HygroLab 3 Bench Top Humidity Temperature Indicators and Brinkmann Titrino Titrators. Reported moisture quantitative/statistical data from Masterfoods products to development lab.
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Education
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Penn State University
Bachelor of Science (BS), Biology, General