Shreyas Laghate
QC Specialist (Scientist) at Emergent BioSolutions- Claim this Profile
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English Full professional proficiency
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Hindi Native or bilingual proficiency
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Marathi Native or bilingual proficiency
Topline Score
Bio
Experience
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Emergent BioSolutions
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United States
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Biotechnology Research
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700 & Above Employee
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QC Specialist (Scientist)
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Apr 2020 - Present
-Responsible for development, validation and implementation of new QC methods and instruments for chemistry, microbiology or raw materials as per site requirements. Updating existing QC method per revised compendial guidance. -Responsible for authoring change controls, deviations and investigations. -Responsible managing and coordinating vendor and CTLs, reviewing external reports and data analysis. -Spearheaded laboratory investigations and provided oversight on the content of… Show more -Responsible for development, validation and implementation of new QC methods and instruments for chemistry, microbiology or raw materials as per site requirements. Updating existing QC method per revised compendial guidance. -Responsible for authoring change controls, deviations and investigations. -Responsible managing and coordinating vendor and CTLs, reviewing external reports and data analysis. -Spearheaded laboratory investigations and provided oversight on the content of investigation reports. Initiated data analysis and provided strategic recommendations to key stakeholders of the investigations. -Developed educational slide decks in partnership with key stakeholders to train and educate analysts/management on new instrumentation, techniques, and test methods. -Introduced project tracking to the group by deployment of Monday boards and Smartsheet. Show less -Responsible for development, validation and implementation of new QC methods and instruments for chemistry, microbiology or raw materials as per site requirements. Updating existing QC method per revised compendial guidance. -Responsible for authoring change controls, deviations and investigations. -Responsible managing and coordinating vendor and CTLs, reviewing external reports and data analysis. -Spearheaded laboratory investigations and provided oversight on the content of… Show more -Responsible for development, validation and implementation of new QC methods and instruments for chemistry, microbiology or raw materials as per site requirements. Updating existing QC method per revised compendial guidance. -Responsible for authoring change controls, deviations and investigations. -Responsible managing and coordinating vendor and CTLs, reviewing external reports and data analysis. -Spearheaded laboratory investigations and provided oversight on the content of investigation reports. Initiated data analysis and provided strategic recommendations to key stakeholders of the investigations. -Developed educational slide decks in partnership with key stakeholders to train and educate analysts/management on new instrumentation, techniques, and test methods. -Introduced project tracking to the group by deployment of Monday boards and Smartsheet. Show less
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Charles River Laboratories
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United States
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Biotechnology Research
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700 & Above Employee
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Senior Research Analyst
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Apr 2019 - Apr 2020
-Structural characterization of biopharmaceuticals using spectroscopic and chromatography based methods with a focus on the higher order structure and understanding any modifications that impact it. -Coordinating with clients to understand their regulatory requirements and providing technical support for biophysical and chromatographic methods. -Contributed data visualization and write ups for studies conducted on site for clients’ BLA and IND filings. -Cultivated strong relationships… Show more -Structural characterization of biopharmaceuticals using spectroscopic and chromatography based methods with a focus on the higher order structure and understanding any modifications that impact it. -Coordinating with clients to understand their regulatory requirements and providing technical support for biophysical and chromatographic methods. -Contributed data visualization and write ups for studies conducted on site for clients’ BLA and IND filings. -Cultivated strong relationships with clients, leadership team and vendors. -Performed method development and method troubleshooting, development and characterization lead for testing and characterization of bio-therapeutics using biophysical and chromatography instrumentation. -Generated detailed reports and presentations for developed methods to be presented at conferences and expositions.
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Research Analyst II
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Jul 2016 - Apr 2019
-Performing detailed biophysical and biochemical protein characterization by using various techniques such as Surface Plasmon Resonance, Mass Spectrometry, Differential Scanning calorimetry, Analytical Ultracentrifugation, Size Exclusion Chromatography, Circular Dichroism, Intrinsic Tryptophan Fluorescence and more. -Presented poster, Circular Dichroism of Protein-Dye Complexes as a characterization Tool for Protein Higher Order Structures at Eastern Analytical Symposium based on work done… Show more -Performing detailed biophysical and biochemical protein characterization by using various techniques such as Surface Plasmon Resonance, Mass Spectrometry, Differential Scanning calorimetry, Analytical Ultracentrifugation, Size Exclusion Chromatography, Circular Dichroism, Intrinsic Tryptophan Fluorescence and more. -Presented poster, Circular Dichroism of Protein-Dye Complexes as a characterization Tool for Protein Higher Order Structures at Eastern Analytical Symposium based on work done in the lab.
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Blue Stream Laboratories
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Woburn, Massachusetts
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Research Analyst Co-op
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Jul 2015 - Jul 2016
Performing detailed biophysical and biochemical protein characterisation by using various techniques such Analytical Ultracentrifugation, Size Exclusion Chromatography, Circular Dichromism, Intrinsic Tryptophan Fluorescence and more. Performing detailed biophysical and biochemical protein characterisation by using various techniques such Analytical Ultracentrifugation, Size Exclusion Chromatography, Circular Dichromism, Intrinsic Tryptophan Fluorescence and more.
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Education
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Northeastern University
Master's Degree, Pharmaceutical Sciences -
Poona College of Pharmacy
Bachelor's Degree, Pharmaceutical Sciences