Sanjal Shah
Plainsboro,NJ
Overview
3
3
years of professional experience
Work History
Analytical Scientist II @Ligand binding
SYNEOS HEALTH
Princeton, NJ
09.2023 - Current
- Performed analytical and bioanalytical assays in compliance with Good Laboratory Practices (GLP) and established Standard Operating Procedures (SOPs).
- Followed FDA regulatory guidelines, including 21 CFR Part 58 (GLP) and 21 CFR Part 11 for data integrity and documentation practices.
- Maintained accurate and contemporaneous laboratory documentation, including raw data recording, logbooks, and assay reports to ensure audit readiness.
- Assisted in quality assurance activities, including review of assay data for accuracy, completeness, and compliance with regulatory requirements.
- Ensured proper sample handling, labeling, storage, and traceability in accordance with GLP standards.
- Supported internal audits and inspections by maintaining organized records and adhering to compliance checklists.
- Identified and reported deviations and assisted in the implementation of Corrective and Preventive Actions (CAPA) under supervision.
- Demonstrated adherence to data integrity principles (ALCOA+) during experimental execution and reporting.
- Collaborated with cross-functional teams to meet study timelines while maintaining regulatory compliance and quality standards.
Infectious Disease Co-op @ Systems Immunology
MODERNA
Cambridge, MA
01.2023 - 06.2023
- Performed cell counting, cell sorting, and biomarker detection using a multicolor flow cytometer (LSR Fortessa II) and analyzed data using FlowJo/FACSDiva.
- Developed and validated SOPs for the Intelliflex Luminex, carried out systems immunology assays to investigate antibody activity in mRNA vaccine macrophages, and executed statistical analysis using GraphPad Prism.
- Mastered in-vitro cell culture and treatments using primary human and mouse cells, and engineered cell lines.
- Created and optimized a high throughput multiplex binding assay SOP to characterize 454 in vivo mRNA 1283 samples over two days using ELISA, LUMINEX.
- Performed Immunology techniques like Cell Growth, culturing cell lines, cell counting using Luna Biosystems and Hemocytometer, Splitting Cells, FACS, Flow Cytometer (Cytotex,, Que, BD Fortessa), ELISA, Luminex, MSD for ongoing studies on vaccines.
- Optimized and validated pre-designed assays in 96 well plates to ensure specificity to the target of interest.
Research Intern
Northeastern University
Boston, MA
09.2022 - 12.2023
- Presented a Hypothetical Drug as GnRH Inhibitor for the treatment of Polycystic Ovary Syndrome.
- Design, plan, and execute in vitro and in vivo experiments to generate preclinical data that supports the development of technology platform as a hypothetical drug.
- Performed Bacterial transformation using E. coli by chemical and heat shock method demonstrating aseptic handling techniques for gradual scale-up to express GFP.
Education
Master of Science - Biotechnology
Northeastern University
05.2023
Post Graduate Diploma -
National Forensic Science Institute
08.2021
Bachelor of Science - Biotechnology
St Xavier's College
10.2020
Skills
- PK/ADA assays
- ELISA
- Bead-based assays
- ElisaSpot
- ECL
- AlphaLISA
- Assay development and optimization
- MSD
- Luminex (FlexMap3D and IntelliFlex)
- Octet
- Veeva Vault
- Microsoft Word
- PowerPoint
- Outlook
- Excel
- Adobe Creative Suite
- GraphPad Prism
- WATSON
- SoftMax pro GxP
- Data Integrity (ALCOA)
Timeline
Analytical Scientist II @Ligand binding
SYNEOS HEALTH
09.2023 - Current
Infectious Disease Co-op @ Systems Immunology
MODERNA
01.2023 - 06.2023
Research Intern
Northeastern University
09.2022 - 12.2023
Master of Science - Biotechnology
Northeastern University
Post Graduate Diploma -
National Forensic Science Institute
Bachelor of Science - Biotechnology
St Xavier's College