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CONTACT
Cary, NC *****
*************@*****.***
Bold Profile
SKILLS
• Time management proficiency
• Laboratory information systems
• Team management
• Data interpretation
• Instrument maintenance
• Technical troubleshooting
• Documentation skills
• Inventory control
• Aseptic technique
• Peer reviews
• Training and mentoring
CERTIFICATIONS
• Medical Laboratory Technician (MLT)
- American Medical Technologists
(AMT).
• American Society for Clinical
Pathology (ASCP).
LANGUAGES
English
Gujarati
Hindi
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth. WORK EXPERIENCE
April 2025 – September 2025
Senior Scientist /Quality Control Analyst / Kriya Therapeutics,Inc Morrisville,NC
• Supported QC testing activities for gene therapy products in a cGMP laboratory following established SOPs and data integrity practices.
• Performed HPLC and related analytical testing for in-process and stability samples supporting development and manufacturing activities.
• Applied aseptic techniques during sample handling and preparation to maintain compliance and contamination control.
• Managed sample receipt, tracking, and documentation within regulated systems ensuring proper chain-of-custody.
• Conducted visual inspection and quality checks to verify compliance with laboratory and batch requirements.
• Maintained accurate GMP documentation aligned with ALCOA+ principles.
• Collaborated with QC and manufacturing teams to support release testing and daily laboratory operations.
• Assisted with deviation documentation and supported investigation activities through accurate data recording.
• Maintained a clean, organized, and inspection-ready laboratory environment
January 2021 - January 2025
Senior Scientist AMP/ Thermo Fisher Scientific, Durham, NC
• Perform analytical development experiment on a research sample using molecular biology techniques such as ddPCR, qPCR, ELISA, SDS- PAGE, Bioburden, Endotoxin, Osmolality and agarose gel electrophoresis to support method development and to evaluate the expression of genes
• Perform Data entry into laboratory information management system
(LIMS)
• Assist with supply inventory functions, general clean-up of laboratory workstations including biohazard trash removal, and help to organize laboratory work area
• Performed and Maintain Laboratory safety programs, monthly safety audits, SDS, laboratory chemical and reagents inventory February 2019 - January 2021
Associate Scientist Catalent, Pharma Solutions, Morrisville, NC
• Perform analytical and physical testing for in process, finish product and stability drug products/ drug substances by HPLC/UPLC using empower
SEJAL PATEL
• Perform sample preparation and testing by following company SOP's and established test method in accordance with GMP guidelines and FDA regulatory procedures
• Review and record analytical data and reported test results in compliance with regulatory requirements
• Conducted method validation and method development procedures
• Utilize TrackWise investigations, to carefully document out-of-trend and out-of-specification results
• Maintaining personal safety and lab cleanliness, including 5S system to maintain laboratory efficiency
• Draft and review certificates of analysis, data trend tables and text reports for report submission for accuracy and compliance paying close attention to detail
January 2017 - February 2019
Medical Technologist LabCorp (LipoScience-Global Research Service), Morrisville, NC
• Received and Opens packages containing clinical research samples and evaluates for quality and quantity
• Operate and conduct daily maintenance, calibration and quality control tasks for NMR laboratory instruments Vantera to ensure accurate results
• Maintain all tracking logs for specimen receiving, processing and NMR instrument analysis
• Maintain and monitor safety at work, conduct regular safety inspection in the lab and surrounding areas
• Conduct quarterly safety meeting with safety committee members to discuss and address safety related issues
• Maintain and update chemical inventories and SDS in the lab January 2009 - January 2015
Microbiologist II NC Department of Agriculture, Food and Drug Protection Division, Raleigh, NC
• Microbiological analysis of water and food products using the BAM and rapid detection methods, with organism identification
• Isolation and identification of microorganism such as culture media, plating, bacterial staining, colonies count, aseptic processing, use of Qualicon BAX qPCR, VIDAS, VITEK 2 compact, Pathatrix, and rapid kit methods
• Performed numerous molecular biology techniques: DNA extraction, amplification by Real-time qPCR and primer/probe design, DNA sequencing, extraction and purification
• To develop daily reports and document findings into laboratory information systems
EDUCATION
Associate of Science Medical Lab Technician
Alamance Community College, Graham, NC
Bachelor of Science Microbiology
Sardar Patel University, Vidhyanagar, Gujarat, India
.