Determined and well-rounded individual with extensive experience in Bio-Pharmaceutical industry. Sharp and focused professional offering skills in mRNA, LNP, Molecular Biology, batch production, Quality Control, Batch data reviewing, Analytical Development, LCMS/MS, HPLC, cGMP, GXP, GDP and Lab operation.
Hi, I’m
KUSHAN PATEL
Germantown,MD
Summary
Overview
12
years of professional experience
Work History
Pharmaron
Bioanalytical Scientist
12.2023 - Current
Job overview
- Collaborates with lead scientist in overseeing execution of LC-MS/MS assay development, validation, and sample analysis activities.
- Contributes to provide training, monitoring, and mentoring of staff as necessary.
- Leads and/or participates in department-initiated process improvements, as required.
- Prepares or reviews standard operating procedures for use by the Company, as required.
- Good understanding of FDA bioanalytical method validation guideline.
- Prepares data tables and reports within Laboratory Information Management Systems (WatsonTM).
Moderna
QC Lab Operation, Reviewer
06.2023 - 10.2023
Job overview
- Performs routine analytical chemistry, bioassay & microbioliogy batch review of mRNA based cancer vaccine and reporting of data generated through the laboratory tests including HPLC/ UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, Osmolality, pH, Appearance, Bioburden , Endotoxin etc.
- Perform data review in LIMS and in paper worksheets if applicable.
- Ensure all laboratory tests are performed correctly and meet cGMP and GDP compliance requirements.
- Ensures timely and successful execution of the assigned data review and data management task.
- Supports Troubleshooting of methods and equipment.
- Perform data entry and support Certificate of Analysis generation as needed.
- Assist in regulatory, customer and internal quality audits that involve data review and data management.
- Assist in test scheduling as necessary (e.g., when tests needs to be repeated based on data review) to meet the project timelines.
- Support authoring quality systems records such as deviations, change controls, CAPAs, OOS/OOT/OOE etc.
- Establish and maintain a safe working environment.
Thermo Fisher Scientific
QC Documentation Reviewer I, Analytical Laboratory
02.2022 - 06.2023
Job overview
- Perform detailed document quality review of protocols, method development reports, study reports, and corresponding original data and documentation to verify integrity of data in support of regulatory submission.
- Performed batch Data Review of various analytical experiments such as Dissolution, pH, Appearance, Disintegration and stability and cleaning validation.
- Review of HPLC & LC-MS/MS data, audit trails, sample sequence, Instruments Logbook, usage books, electronic books and daily verification logs.
- Ensures compliance to GDP/GMP expectations.
- Identify deviations, OOS and OOT & ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
- Working as liaison between QA/QC & collaborated with other departments to establish cohesive laboratory operations.
Eurofins Experchem
Research Analyst II
10.2019 - 02.2022
Job overview
- Developed,validated,conducted,and troubleshooted Liquid Chromatography- Mass Spectrometry (LC-MS/MS) based methods for various applications.
- Worked with scientific and engineering teams to improve research and project plans by sharing scientific knowledge.
- Performed batch acquisition and data processing by using scientific software.
- Wrote and reviewed protocols and SOPs.
- Interacted with QA to ensure all audit findings are addressed in a timely fashion.
- Adhered to corporate standards regarding code of conduct, safety, and GLP/GCP/GDP compliance.
Veeda Clinical Research Ltd.
Senior Research Associate
05.2015 - 08.2018
Job overview
- Developed bioanalytical assays including LC-MS/MS to support bioanalysis of small molecules, oligonucleotides, peptides, proteins, and metabolites in a variety of biological fluid and tissue samples.
- Performed Method development, Method transfer and Method validation on LC-MS/MS on different platforms including triple quadrupole & QTRAP.
- Conducted laboratory experience and research in compliance with the regulatory standards of FDA, GLP, GMP, GCP,EMEA and ANVISA.
- Collected data from experiments, perform data analysis and interpret experimental results. Provided accurate and timely results. Generated electronic audit trail.
- Authored and/or reviewed key regulatory documents, laboratory data, SOP and technical reports.
- Worked with management and QA to maintain and improve quality systems.
Lambda Therapeutic Research Ltd.
Senior Research Associate
03.2012 - 05.2015
Job overview
- Performed Bio Analytical assay development, validation, troubleshooting and sample analysis for non-clinical and clinical studies from different therapeutic areas.
- Performed routine lab operations, such as sample extraction (SPE,LLE,PPT), preparing reagents, pipetting, weighing, monitoring, and recording.
- Independently operated LC-MS/MS and HPLC & conduct routine maintenance.
- Ensured effective implementation of GLP and 21 CFR. Work as per OECD GLP principles.
- Recognized and reported unexpected or Out Of Specification (OOS) results immediately to the supervisor and conduct laboratory investigation under direction.
Education
Curtin University
Master in Bio Medical Science from Major In Molecular Biotechnology
University Overview
- Coursework in Molecular Techniques, Vaccine Science, Biotechnology, Bioinformatics, Molecular Genetics.
Rajiv Gandhi University Of Health SciencesIndia
Bachelor from Pharmacy
University Overview
- Coursework in Bio Chemistry, Microbiology, Pharmaceutical Production, Analytical Chemistry & Instrumentation, Medicinal Chemistry & Pharmacology
Skills
- Attention to detail
- Self-Motivated
- Organization and Time Management
- Decision-Making
- CAPA/Deviations/OOS Investigation
- Batch Reviewing and Analysis
- cGMP, GXP,GDP & GLP
- Troubleshooting
- LC-MS/MS and HPLC
Accomplishments
Accomplishments
- AB Sciex series (API2000, API4000, 5500, 6500)
- Shimadzu series (8040, 8050 and 8060)
- Agilent 1260 infinity II,HPLC (Variable Wavelength Detector, UV-vis)
- The Waters Acquity UPLC
- Thermo Fisher's Vanquish Flex UHPLC (Variable Wavelength Detector)
PROFICIENT IN SCIENTIFIC SOFTWARE:
PROFICIENT IN SCIENTIFIC SOFTWARE:
- Veeva Vault
- Smart QC
- Smart Sheet
- SAP
- Analyst software by AB Sciex
- LabSolutions by Schimadzu Scientific
- Agilent's OpenLab Software
- Empower Chromatography Data System- Water's Corporation
- NuGenesis SDMS by Waters
- Watson LIMS
- Labvantage
- Trackwise
- Chromeleon
Additional Information
Additional Information
- Canadian Citizen and can work on TN visa
- Ready to relocate and join immediately
Timeline
Bioanalytical Scientist
Pharmaron
12.2023 - Current
QC Lab Operation, Reviewer
Moderna
06.2023 - 10.2023
QC Documentation Reviewer I, Analytical Laboratory
Thermo Fisher Scientific
02.2022 - 06.2023
Research Analyst II
Eurofins Experchem
10.2019 - 02.2022
Senior Research Associate
Veeda Clinical Research Ltd.
05.2015 - 08.2018
Senior Research Associate
Lambda Therapeutic Research Ltd.
03.2012 - 05.2015
Curtin University
Master in Bio Medical Science from Major In Molecular Biotechnology
Rajiv Gandhi University Of Health Sciences
Bachelor from Pharmacy
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