Kintan Patel
Iselin
Summary
Analytical R&D Scientist with 9+ years of experience in a fast-paced Pharmaceutical CDMO (Contract Development and Manufacturing Organization) environment . Proven track record of developing, validating, and transferring robust analytical methods for diverse drug substances and drug products. Expert in managing multi-client project timelines, authoring regulatory-compliant documentation, and resolving complex technical challenges under tight cGMP timelines. Understand GMP and follow instructions on the documents.
Personal Strength:
- Project/Time Management
- Problem Solving-Skills
- Quick learner
- Adaptability/Flexibility
Overview
10
10
years of professional experience
Work History
AR&D Scientist
Halo Pharma, Whippany, NJ
02.2022 - Current
- Validated analytical methods HPLC, UHPLC,Dissolution(Apparatus I&II) and Gas Chromatography) for diverse chemical entities according to ICH guidelines.
- Executed technology transfers of analytical methods from client sites to internal QC labs, ensuring zero data gaps.
- Developed and optimized Standard Operating Procedures (SOPs) for (Malvern 3000)wet and dry powder dispersion units (Hydro and Aero systems) to reproducible results
- Conducted stability studies to assess product shelf life and efficacy.
- Managed tech transfers for client projects from R&D to commercial manufacturing scale.
- Collaborate with cross-functional project team to ensure all project deliverables are met on-time.
- Participated in project meetings, providing insights on analytical challenges and potential solutions to enhance outcomes.
- Led cross-functional teams to develop innovative drug formulations and processes.
- Contribute to project planning, timeline management, and project milestone deliverables to ensure successful project.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
Analytical Scientist
Appco Pharma LLC
Piscataway, NJ
09.2021 - 02.2022
- Conducted complex data analysis to support drug development and formulation optimization.
- Participated in project meetings, providing insights on analytical challenges and potential solutions to enhance outcomes.
- Improved analytical methods by developing and implementing new protocols for sample preparation and data analysis.
- Streamlined laboratory workflows, improving efficiency and reducing turnaround times for analyses.
- Maintained accurate documentation of experimental procedures, results, and conclusions as per regulatory guidelines and internal policies.
- Collaborated with R&D teams to troubleshoot and resolve issues in assay development processes.
AR&D Chemist
Core Pharma LLC, Middlesex, NJ
09.2019 - 09.2021
- Performed Method Development and Validation of drug products and drug substances using chromatographic techniques like HPLC, UHPLC, Gas chromatography
- Analyzed drug substances, excipient, and experimental products to provide information to product development team.
- Analyzing excipient and wet chemistry testing using in-house and USP test methods
- Established degradation profiles for drug substance and drug products.
- Performed stability studies for new drug products as well as the evaluation of stability data required for ANDA submission
Analytical Chemist
Invatech Pharma, East Brunswick, NJ
04.2017 - 09.2019
- Collaborated with cross-functional teams to troubleshoot analytical issues and optimize processes.
- Implemented improvements in laboratory workflows, enhancing efficiency and accuracy of analysis.
- Analyzed drug substances, excipient, and experimental products to provide information to product development team.
- Managed equipment calibration and maintenance schedules to ensure operational readiness of analytical instruments.
- Performed analysis of pharmaceutical finished products using various methods to test for purity.
Analytical Chemist
Avik Pharmaceutical PVT LTD
India
06.2016 - 02.2017
- Supported inventory management by tracking chemical supplies and reagents for laboratory use.
- Performed routine maintenance on analytical instruments to ensure optimal performance.
- Engaged in training sessions to enhance knowledge of safety protocols and regulatory compliance standards.
- Performed analysis of pharmaceutical finished products using various methods to test for purity.
Education
Master of Science - Organic Chemistry
Uka Tarsadia University
India01-2016
Bachelor of Science - Chemistry
VNSGU
India01-2014
Skills
- Techniques: HPLC/UHPLC, Gas Chromatography,UV/Vis Spectroscopy, Particle Size Analysis, Dissolution Testing,Karl-Fisher
- Industry Standards: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), FDA/EU,TGA,ANVISA regulations, ICH guidelines
- Functions: Analytical Method Development, Method Validation, OOS (Out of Specification) Investigations, Stability Studies,Tech transfer activity
- Software: Empower 3, Microsoft Excel and Microsoft word Novatek Stability Management Software,Malvern Mastersizer 3000
Languages
English
Timeline
AR&D Scientist
Halo Pharma, Whippany, NJ
02.2022 - Current
Analytical Scientist
Appco Pharma LLC
09.2021 - 02.2022
AR&D Chemist
Core Pharma LLC, Middlesex, NJ
09.2019 - 09.2021
Analytical Chemist
Invatech Pharma, East Brunswick, NJ
04.2017 - 09.2019
Analytical Chemist
Avik Pharmaceutical PVT LTD
06.2016 - 02.2017
Master of Science - Organic Chemistry
Uka Tarsadia University
Bachelor of Science - Chemistry
VNSGU