Alpesh S.
Principal Scientist @Vwr, Part Of Avantor
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WORK HISTORY
Principal Scientist @Vwr, Part Of Avantor
Cleveland, OH, US
Lead analytical method validation, qualification, and lifecycle management to ensure methods remain robust, compliant, and fit for intended use.•Oversee OOS/OOT investigations, root cause analysis, and CAPA aligned with OSHA, GMP, and internal quality systems.•Prepare and review technical documents: validation protocols & report, summary reports, change controls, deviation reports, change control, SOPs, and method process descriptions.•Manage new analytical projects, timelines, and deliverables across cross functional teams.•Transfer analytical methods from Product Research and Development laboratories with an emphasis on communication with other analytical scientists while making improvements on test methods to improve robustness, accuracy, precision and other attributes outlined by ICH guidelines.•Maintain validated state of laboratory instruments within time frame, lead instrument upgrades, software updates, and CAPEX planning.•Promote safe laboratory practices and ensure compliance with OSHA and EHS programs.•Serve as a subject matter expert (SME) and technical mentor for team members; provide guidance on experimental design, data interpretation, and problem-solving.
EDUCATION
ACCT Healthcare USA
Master's degree, Computer Information Systems in Healthcar
Gujarat Technological University (GTU)
Master's degree, Pharmacy
Gujarat Technological University
Master's degree, Pharmacy
ABOUT ALPESH S.
Mentoring team and trained them on method development, validation, troubleshooting of instruments.•Planning and delegating workflow based on project timelines and business priorities to ensure timely deliverables.•Conducting technical discussions, Presentation with cross-functional teams to align analytical strategy with project goals.•Ability to develop, improvements to existing methodologies & validate analytical methods using modern analytical instruments such as HPLC/UPLC, Dissolution, GC, MS, KF, TGA, DSC, XRD, ICP, particle analysis, Osmolality, viscosity, density, pH, Rheometer, Polarimeter, Conductometer, Refractometer, Microscopy etc. using different software’s e.g. LIMS, track wise, Empower, Mass Hunt, Lab solution, Chromeleon along with trouble shoot all analytical instruments and maintain it.•Perform routine stability samples testing with different existing batches, perform force Degradation study and in-depth discussion with the formulation department about improving the product.•Perform Extraction and Leachable study using ICP-MS and trained for LC-MS/MS and GC-MS (Scouting and Quant using Orbitrap-Discover, Q-TOF-SCIEX, DI, Headspace with Mass Hunter).•Dosage forms Experience: Injectable, gel, ointment, cream, solution, suspension, complex product.•Utilizes analytical technical skills to perform in-depth investigations for out of specification (OOS), out of trend results (OOT) and aberrant data. Draw conclusions and perform root cause analysis investigations and recommend solutions to prevent recurrence.•Oversee OOS/OOT investigations, root cause analysis, and CAPA aligned with OSHA, GMP, and internal quality systems.•Writing and review- method, Protocols, reports, SOP, Test Processer, risk assessment report, control change, tech transfer documents.•Expand knowledge with Maintain current expertise through reading articles, discussion with peers, cross knowledge transfer and attending technical courses.•Routing Analysis: Element Imp study, Find PDE Value in extractable containers, Material Compatibility Study, Excipient compatibility study, Stability study, Force Degradation profile study with mass balance, Impurity Extraction, Impurity profile Study, product Assay Study, Dissolution release profile study (I, II, IV, Nano Dis), Particle size, Osmolality, Extractable study for different doses forms product.
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