Journal of Clinical & Experimental Pharmacology

Binit Patel

Biography

I am an accomplished Analytical Scientist with 14 years of extensive experience in analytical chemistry, specializing in the development, validation, and characterization of pharmaceutical drug substances, drug products, and discovery compounds using advanced analytical platforms such as UPLC, HPLC, LCMS, GC, UV, DSC, and FTIR. Over the past decade, I have operated within FDA-regulated R&D environments, ensuring full compliance with regulatory requirements for IND, NDA, 505(b)(2), and ANDA submissions. I play a key role in supporting Quality Risk Management (QRM) activities across internal development programs and contract manufacturing organizations (CMOs), driving the implementation of effective risk mitigation strategies in alignment with global regulatory expectations. My responsibilities include identifying and resolving technical gaps, providing strategic scientific guidance during formulation and process development, and leading cross-functional teams to achieve project milestones within defined timelines. In addition, I possess strong leadership and vendor management capabilities and actively contribute to the scientific community through research publications and peer reviews, demonstrating a sustained commitment to advancing pharmaceutical science and innovation.

 

 

 

 

 

 

 

PROFESSIONAL EXPERIENCE

• Sr. Drug Product Analytical Scientist at Exemplify Biopharma Inc, New Jersey, USA from July 2025 to Present.
• Analytical Scientist (Analyst) at Hovione LLC, New Jersey, USA from May 2023 to July 2025.
• Analytical Chemist II at Havix Group Inc (d.b.a. Aavis Pharmaceuticals) at Georgia, USA, from October 2022 to April 2023.
• Research Scientist II in Analytical Development Laboratory at Xylopia Labs Pvt. Ltd, Gujarat, India, from October 2016 to September 2022.
• Senior Research Fellow in Analytical Development Laboratory at Emcure Pharmaceutical Limited, Gujarat, India, from December 2013 to September 2016.
• Research Associate in Analytical Development Laboratory at Zydus Cadila (Zydus Lifesciences) from August 2012 to December 2013.

KEY TECHNICAL SKILLS

• Method development of Dissolution, Assay and Impurities, Impurity Risk Assessment and Cleaning validation for various drug substances and drug products such as Solid Oral, Transdermal and Injectables to support NDA, ANDA and ANADA fillings.
• Development of new methods for In vitro drug release profiling of IND molecules as well Generic Drug Product.
• Develop and validate novel analytical techniques for New Drug Molecules to support phase 1 to phase 3 study.
• Perform impact assessment as well develop new analytical techniques for quantitative evaluation of Nitrosamine Impurity for drug products and drug substance.
• Perform method validation and method transfer of developed analytical methods using analytical instruments to the QC site as per regulatory guidelines, along with the preparation and review of protocols, reports for method development, validation, specifications, stability studies, and analytical method STPs for assigned projects.
• Leading project from drug substance development to final method transfer of finished drug product for regulatory submission for NDA as well generic drug products.
• Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and ANDA submissions.

• Responsible for Market complaint investigations. Leading, conducting, writing, reviewing and preparing product quality complaint (PQC) investigations.

• Prepares, reviews, and edits stability, qualification, and method validation protocols, analytical technical reports, and CMC regulatory documentation.
• Maintain close contact with many stakeholders working on the same project while maintaining effective communication to troubleshoot major issues and meet deadlines.
• Calibration of analytical instruments such as pH meter, UV Spectrophotometer, Dissolution Apparatus USP I & USP II (Make: Electrolab, Agilent, Varian), HPLC and UHPLC (Make: Waters, Shimadzu, Thermo-scientific and Agilent) and many more.
• Managing multiple projects and drive the development in a cross functional environment with predefined timeline.
• Responsible for Analytical Method troubleshooting and technical transfer of method of allotted projects.
• Responding to regulatory queries and getting appropriate solution within provided timeline for Information request and complete response.
• Investigated OOS and timely guidance to QC and Validation Department.
• Maintains knowledge of the latest guidelines of regulatory requirements of ICH, USP, USFDA and OSHA.

 

INSTRUMENTATION SKILLS

• Dissolution Apparatus – SOTAX, Hansen, Agilent Tech., Distek, Electrolab, Lab India
• HPLC and UHPLC – Waters, Shimadzu, Agilent, Dionex (Thermo Scientific)
• Gas Chromatography – Agilent, Shimadzu
• Franz Diffusion Cell – New Meditech, Logan Instruments Corp.
• Particle Size  – Malvern Mastersizer
• UV/Vis Spectrophotometer and FTIR – Shimadzu, Agilent
• XRPD – RIGAKU
• Additionally, all other instruments are used in Analytical Laboratory

 

 

 

SOFTWARE SKILL

Empower, Chromeleon 6.8 and 7.2, Chemstation, Open Lab CDS, LC Solution, Documentum, LIMS, BIOVIA (Electronic Logbook) and Microsoft office.

 

EDUCATIONAL QUALIFICATIONS

• Master of Pharmacy (Master of Science Degree in Pharmaceutical Science), Rajiv Gandhi Proudyogiki Vishwavidyalaya (University of Technology of Madhya Pradesh), India.
• Bachelor of Pharmacy (Bachelor of Science Degree in Pharmaceutical Science), Veer Narmad South Gujarat University, India.

 

RESEARCH AND REVIEW PUBLICATION

1. 2011: BV Patel, Dhara Patel., Study of Disintegrant Property of Moringa Oleifera Gum and its Comparison with other Superdisintegrants. International Journal of ChemTech Research., 2011: 3(3), 1119-1124.
2. 2012: B Patel, N Chobey, Evaluation of moringa oleifera gum as tablet disintegrant, IJPPS, 2012: 4(1), 210-214.

4. 2023: B Patel, V Prajapati, S Parikh, Analytical method development and validation for the estimation of Fosfomycin trometamol in its bulk and pharmaceutical dosage form. Paripex -Indian Journal Of Research, 2023, 12(4).
5. 2023: N Bhatt, H Patel, D Patel, B Patel, Development and Optimization of Macitenan Loaded Self-Micro Emulsifying Tablets, Journal of Chemical Health Risks, 2023, 13(6), 486-499.
6. 2023: Ravi Patel, Ravisinh Solanki, Zeeshan Shaikh, Sanjay Chauhan, Shalin Parikh, Binit Patel. Development of in vitro dissolution test method for bilastine and montelukast fixed-dose combination tablets. Dissolution Technologies, 2023, 11(1), 246-250. dx.doi.org/10.14227/DT300423P246
7. 2024: Pravinkumar Darji, Binit Patel, Arpan Chudasama, Praneeth Ivan Joel Fnu, Seshadri Nalla, Formulation and Evaluation of Nebivolol Loaded Nanosponges for Oral Drug Delivery, Journal of Chemical Health Risks, 2024, 14(2), 1702-10.
8. 2024: Binit Patel, Pravinkumar Darji, Arpan Chudasama, Praneeth Ivan Joel Fnu, Seshadri Nalla, Preparation, Characterization, and Evaluation of a Novel Co-Processed Excipient as a Directly Compressible Vehicle in Antihypertensive Tablet Formulation, Journal of Chemical Health Risks, 2024, 14(2), 1711-17.
9. 2024: Mahaveer Singh, Virat kumar Khatri, Dhanalakshmi. H, Binit Patel, Pravinkumar Darji, Jailani. S, Avidit Sharma, Gagandeep Singh, Dr. Meenu Rani., Development and evaluation of floating tablets of atenolol using hydrophilic and hydrophobic polymers, 2024, 6(Si-2), 808-821.
10. 2024: Meenal Patil, Gurmeet Singh Chhabra, Pravinkumar Darji, Binit Patel, Praneeth Ivan Joel Fnu, Seshadri Nalla, Viratkumar Khatri. Optimized RP-HPLC Method for the Quantification and Validation of Amlodipine and Irbesartan. Journal of Chemical Health Risks, 2024, 14(3), 1150-60.
11. 2024: Pravin Darji, Jayendra Patel, Binit Patel, Shalin Parikh, Praneeth Ivan Joel Fnu, Comprehensive Review on Oral Biologics, World Journal of Pharmaceutical Research, 2023, 13(3), 1217-49.
12. 2024: P kumar Darji, J kumar Patel, B Patel, S Parikh, PIJ Fnu. Overview on Osmotic Drug Delivery System. International Journal of Pharmaceutical Research and Applications, 9(1), 86-100.
13. 2024: Pravinkumar Darji, Jayendrakumar Patel, Binit Patel, Arpan Chudasama, Praneeth Ivan Joel Fnu, Seshadri Nalla. Recent Methods to improve stability profile, pharmacokinetic and pharmacodynamic properties in anticancer drugs. World Journal of Pharmaceutical and Life Sciences, 2024, 10(3), 216-229.
14. 2024: Pravinkumar Darji, Jayendrakumar Patel, Binit Patel, Arpan Chudasama, Praneeth Ivan Joel Fnu, Seshadri Nalla, A Comprehensive Review on Anticancer Natural Drugs., World Journal of Pharmacy and Pharmaceutical Sciences, 2024, 13(4), 717-734.
15. 2024: Pravinkumar Darji, Jayendrakumar Patel, Rakesh Patel, Binit Patel, Virat kumar Khatri, Praneeth Ivan Joel Fnu and Seshadri Nalla, Self-Regulated Anti-Overdose Crush-Resistant Drug Delivery System Designed to Address the Opioid Abuse Crisis, World Journal of Pharmaceutical Research, 2024, 13(10), 997-1014.
16. 2024: Pravinkumar Darji, Jayendrakumar Patel, Shalin Parikh, Binit Patel, Virat kumar Khatri, Praneeth Ivan Joel Fnu and Seshadri Nalla., Development of single layer osmotic controlled release tablet for low soluble drug: Single Core Osmotic Pump (SCOP), World Journal of Advanced Research and Reviews, 2024, 22(02), 1006–1020
17. 2024: Pravinkumar Darji, Jayendrakumar Patel, Binit Patel, Viratkumar Khatri, Praneeth Ivan Joel Fnu, Seshadri Nalla. Comprehensive Review on Drug Discovery and Development Process. Journal of Chemical Health Risks, 2024, 14(3), 2258-2565.
18. 2024: Pravinkumar Darji, Jayendrakumar Patel, Binit Patel, Shalin Parikh, Praneeth Ivan Joel Fnu, Seshadri Nalla. Review on Recent Development in Opioid Abuse-Deterrent Formulation Technologies and Regulatory Expectation. Biomedical & Pharmacology Journal, 2024 17(2):779-793.

PATENTS

HONORED AND AWARDS RECEIVED

• Actively engaged with the global pharmaceutical academia by voluntarily serving as a peer reviewer for several internationally recognized scientific journals, contributing to the advancement of ongoing research in pharmaceutical sciences.

1. AAPS Pharm-SciTech (1 Review)
2. Frontiers in Cellular and Infection Microbiology (1 Review)
3. Chromatographia (6 Review)
4. Biomedical Chromatography (1 Review)
5. Journal of Chromatography B (1 Review)
6. Dissolution Technologies (7 Review)
7. Biosciences Biotechnology Research Asia (8 Review)
8. Biomedical and Pharmacology Journal (17 Review)
9. Indian Journal of Pharmaceutical Education and Research (2 Review)
10. Prospects in Pharmaceutical Sciences (1 Review)

• Also, I am an Editorial Board team member of listed scholarly journal to support research through my pharmaceutical expertise.

1. Journal of Medical and Pharmaceutical Sciences
2. International Journal of Allied Medical Sciences and Clinical Research (IJAMSCR)

Research Interest

I am an accomplished Analytical Scientist with 14 years of extensive experience in analytical chemistry, specializing in the development, validation, and characterization of pharmaceutical drug substances, drug products, and discovery compounds using advanced analytical platforms such as UPLC, HPLC, LCMS, GC, UV, DSC, and FTIR. Over the past decade, I have operated within FDA-regulated R&D environments, ensuring full compliance with regulatory requirements for IND, NDA, 505(b)(2), and ANDA submissions. I play a key role in supporting Quality Risk Management (QRM) activities across internal development programs and contract manufacturing organizations (CMOs), driving the implementation of effective risk mitigation strategies in alignment with global regulatory expectations. My responsibilities include identifying and resolving technical gaps, providing strategic scientific guidance during formulation and process development, and leading cross-functional teams to achieve project milestones within defined timelines. In addition, I possess strong leadership and vendor management capabilities and actively contribute to the scientific community through research publications and peer reviews, demonstrating a sustained commitment to advancing pharmaceutical science and innovation.