Urjasvi Patel
Chicago,IL
Summary
+4 years of experience as analytical scientist in pharmaceutical industry with cGMP regulation. Experience in method development, stability study, validation and in process quality control. Proficient in performing tests, documenting results and writing papers. Good knowledge of cGMP, ICH, USP, GLP. Hands of experience HPLC, GC, UPLC. FTIR, NMR and U.V. spectroscopy. Knowledge with preformulation study, bio analytical assay, advance chromatography (large molecule)
Overview
8
8
years of professional experience
Work History
Analytical Scientist
Catalent Pharma Solutions
09.2019 - 09.2020
- Soft gelatin Capsule, support product development by evaluating and testing raw materials, excipient, APT, in-process and finished product
- Improved analytical methods by developing and implementing new protocols for sample preparation and data analysis.
- Verify results, calculations in note book /logbook and results in report to check for accuracy and integrity of data.
- Assists in complex experiments and tasks such as unknown impurity identification and excipient compatibility studies.
- Support investigation of method performance, reliability and conduct optimization study, as needed
- Participate in preparation of technical document, including validation protocols and reports, reference standard qualification report and analytical test procedure
Analytical Engineer
Nufarm America
12.2017 - 04.2018
- Supporting agriculture products in quality control operations by analyzing raw materials, intermediate batch, packaging and finished products with HPLC, GC, LC-MS, ICP-OES
- Prepare and review documentation to support method validation and/or transfer
- Perform data review and verification
- Investigate out of specification and/or anomalous results
- Draft and revise laboratory SOP
- Performing release and stability testing of products
Research and Development Scientist
Dishman Pharmaceuticals & Chemicals
07.2014 - 01.2016
- Perform preformulation study of topical and opthalmic drug product with HPLC, UPLC, GC, KF, FTIR. conduct IVTR study using Franz Diffusion cell and enhancer cell.
- Method development for assay, impurity profile and residual solvent, method validation of inhouse method and verification of USP compendia method
- Conduct stability testing activity of new product
- Report writing and work on protocol. interpret and communicate analytical report result.
- Maintained accurate documentation of all experiments, facilitating seamless replication or future reference when needed.
- Actively participate in investigation of laboratory when required.
- Implemented safety protocols within lab, ensuring compliance with regulatory guidelines and minimizing potential hazards.
- Learned and adapted quickly to new technology and software applications.
Associate Scientist
Guardian Pharmaceutical
07.2012 - 06.2014
- Oral and topical product: performed testing of raw material, intermediate and final product; reviewed and approved test result.
- Performed chemical stability and structure elucidation including forced degradation, stability studies, extractable and leachable testing and dissolution testing.
- Executing retests and conforming to GLP protocols to volumetrically set up analytical samples
- Maintaining tool calibration logs and documenting results of laboratory experiments
- Performing validation and natural product analysis
Education
Master of Science - Analytical Chemistry
Governors State University
Park Forest, IL05.2018
Master of Science - Pharmaceutical Sciences
APMC College of Pharmaceutical Education & Researc
Himatnagar, India06.2015
Bachelor of Science - Pharmacy
APMC Collage of Pharmaceutical Education
Himmatnagar06.2012
Skills
- Analytical Skill: Hands on experience HPLC, UPLC, GC, Dissolution App I and II, FTIR, UV-Vis, KF, sample preparation (Large molecules), ICP-OES
- Interpersonal Communication
- Hypothesis testing
- Knowledge in Separation Science (SEC, IEC, Gel electrophoresis, Capillary electrophoresis)
- Method development (Small Molecules)
- Knowledge on complex Chromatography Techniques(RP-LC, LC-MS/MS, GC-MS) and bio assay( ELISA, western blot technique)
- Working experience in cGMP environment
- Laboratory and Equipment Management
- Multitasking
- Excellent Communication
- Problem-solving abilities
- Microsoft Excel, power point, minitab, empower,
Timeline
Analytical Scientist
Catalent Pharma Solutions
09.2019 - 09.2020
Analytical Engineer
Nufarm America
12.2017 - 04.2018
Research and Development Scientist
Dishman Pharmaceuticals & Chemicals
07.2014 - 01.2016
Associate Scientist
Guardian Pharmaceutical
07.2012 - 06.2014
Master of Science - Analytical Chemistry
Governors State University
Master of Science - Pharmaceutical Sciences
APMC College of Pharmaceutical Education & Researc
Bachelor of Science - Pharmacy
APMC Collage of Pharmaceutical Education
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