A Senior Scientist with 10 years of experience in analytical development worked with various techniques like ICPMS, ICP-OES,AAS, LC, LC-CAD, RI, LCMS, IC, Disintegration, Dissolution, XRPD, PSD, GC & FT-IR.
An expert on Elemental impurities, De-formulation, Nitrosamine's (Evaluation) and Extractables & Leachables
Performs Impurity charaterization for elemental impurities, extracatbles & leachables.
Expert on digitalization rolled out successfully LabX and ELN to the Sandoz global sites and CSV expert related to user privileges, qualification of instruments in GMP, audit trail risk assessments and to perform periodic reviews to the instruments.
LinkedIn url: krishna-chaitanya-boyina-ab800453/
Overview
11
11
years of professional experience
1
1
Certification
Work History
Senior Scientist
Ingenus Pharmaceutical
Denville, NJ
11.2023 - Current
Expert on Elemental impurities, De-formulation, Nitrosamine's (Evaluation) and Extractables & Leachables on various techniques like ICPMS, LC, LC-CAD, RI, LCMS, ICPOES, AAS, IC, Disintegration, Dissolution, XRPD, PSD & FT-IR
Expert on De-Formulation (Excipient Quantification) and De-coding RLD by LC-CAD, LC-RI, ICPMS & IC
To perform method development & validations by LC and GC for Assay, dissolution, water content and disintegration for Oral solids, Injectables, Transdermal dosage forms and Inhalations.
To perform theoretical assessment for Nitrosamines, Elemental Impurities and analytical evaluation by LCMS & ICPMS
To perform solid state characterization development and validation by PSD, XRPD & FT-IR
To perform qualifications for instruments includes CSV, Software evaluation, user privileges, qualification & audit trail risk assessment and ELN
Senior Scientist
New Jersey Laboratories
New Brunswick, NJ
06.2023 - 11.2023
Expert on Elemental impurities, De-formulation, Nitrosamine's (Evaluation) and Extractables & Leachables on various techniques like ICPMS, LC, LC-CAD, RI, LCMS, ICPOES, AAS, IC, Disintegration, Dissolution, XRPD, PSD & FT-IR
Expert on De-Formulation (Excipient Quantification) and De-coding RLD by LC-CAD, LC-RI, ICPMS & IC
To perform method development & validations by LC and GC for Assay, dissolution, water content and disintegration
To perform theoretical assessment for Nitrosamines, Elemental Impurities and analytical evaluation by LCMS & ICPMS
To perform solid state characterization development and validation by PSD, XRPD & FT-IR
To perform qualifications for instruments includes CSV, Software evaluation, user privileges, qualification & audit trail risk assessment and ELN
Senior Scientist
Sandoz
Hyderabad, Telangana
04.2019 - 03.2023
Expert on Elemental impurities, De-formulation, Nitrosamine's (Evaluation) and Extractables & Leachables on various techniques like ICPMS, LC, LC-CAD, RI, LCMS, ICPOES, AAS, IC, Disintegration, Dissolution, XRPD, PSD & FT-IR.
To perform De formulation (RLD decoding) activities on LC-CAD, LC-RI, ICPMS, IC & LCMS
To perform elemental impurities (ICHQ3D) development and validation by ICPMS
To perform extractable & leachables studies by ICPMS, IC & LCMS
To perform regular support for validations and in process sample analysis for Assay, dissolution, water content and disintegration
To perform theoretical assessment for Nitrosamines, Elemental Impurities and analytical evaluation by LCMS & ICPMS
To perform solid state characterization development and validation by PSD, XRPD & FT-IR
To perform qualifications for instruments includes CSV, Software evaluation, user privileges, qualification & audit trail risk assessment
To maintain Agile POD structure for project management
Scientist
Dr Reddy's
Hyderabad, India
10.2016 - 04.2019
Established ICHQ3D Platform for performing method dvelopment and validations by ICPMS & ICPOES for Oral solids, Injectables & Inhalations
Established Extaractables & Leachables for container closure systems
Peformed NG tube studies by Particle size analysier
Executive
Mylan
Hyderabad, India
05.2013 - 09.2016
Expert in Elemental analysis by ICPMS, ICPOES & AAS
Developed and validated Iron & Sodium methods for Iron Injections
Expert in performing wet analysis (KF, LOD, ROI, SOR, PSD & titrimetry)