Priya Patel
Senior Chemist at Odin Pharmaceuticals, LLC- Claim this Profile
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Bio
Credentials
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Pharmaceutical Manufacturing Practices
Stevens Institute of TechnologyJan, 2013- Nov, 2024
Experience
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Odin Pharmaceuticals, LLC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Chemist
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Sep 2018 - Present
Designed, developed and validated analytical methods (assay, related compound, preservative content and dissolution) for a wide variety of APIs and drug products (Injections , Otic Suspension and Ophthalmic Suspension).Perform Forced degradation studies of various drug products and prepare mass balance reports. Develop Particle Size Distribution test method using Malvern Mastersizer and Viscosity methods using Brookfield Viscometer. Perform Reverse Engineering on drug products for Q1-Q2 Approvals. Critical scientific/technical data analysis and presentation of data in project team meetings.Author, review, and approve Standard Operating Procedures, GMP documents, reports and protocol.Performed preventative maintenance, calibration and troubleshooting of analytical instruments as required.Provide high level of analytical support in conducting pre-validation, full validation, method equivalency and method verification of method for assay, related compounds and preservative content.Execute performance parameters like Accuracy, Method Precision, Linearity, Range, Robustness, and Filter Study.Conduct routine analysis and data process of API and Finished product using HPLC, UPLC and UV-spectrophotometer.Work with Empower-3 software and chromeleon 7 in collecting, processing and generating the chromatographic data.Document work as per the SOPs and Current Good Documentation Practice. Prepare sample solution, stock and working standard preparation, placebo preparation and mobile-phase preparation. Perform calibration of pH meter, Balances, HPLC, UPLC,Viscometer, Density meter, Infrared Spectroscopy, UV-Vis Spectrophotometer and Dissolution Baths (USP-IV).Train new chemists on analytical laboratories instrumentation and procedure. Maintain and Order reference standard inventory and Chemical / Lab Supply inventory.
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Novel Laboratories, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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chemist II
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Jul 2014 - Aug 2018
• Develop qualitative and Quantitative analytical methodologies of in vitro-release drug delivery system to be applied in pharmaceutical projects.• Develop formulas, processes, and test methods in the development of new products. • Executes all tasks and responsibilities in accordance with SOPs and in a fast-paced FDA regulated environment. • Provide leadership, training, and guidance to peers.• Ensures adherence to GMP and FDA rules and regulations throughout testing and analysis.• Responsible for the inspection and calibration all equipment, standards and controls to confirm specifications and standardization’s are current.• Regularly perform laboratory and safety audits as directed by the department manager.• Work in Cross-Functional team to perform QC analysis for various samples of finished product, stability products and in-process materials.• Routinely perform sample analysis for Assay, Impurities and dissolutions by HPLC, UPLC, UV-Vis Spectroscopy and Ion Chromatography.• Work with Empower-3 software and chromeleon 7 in collecting, processing and generating the chromatographic data.• Document work as per the SOPs and Current Good Documentation Practice. • Conduct analytical testing of In-process material for blend uniformity, particle size by sieve analysis, bulk density and tap density.• Prepare sample solution, stock and working standard preparation, placebo preparation and mobile-phase preparation. • Perform calibration of pH meter, Balances, Density meter, and Dissolution Baths (USP-I and USP-II).• Prepare dissolution media and setting up dissolution bath for testings. • Perform analysis of loss on drying on finish product and in-process materials using computrac moisture analyzer.• Perform water content determination using Karl Fischer titration. • Routinely monitor and document temperature, ppb and total organic carbon content for elga pure water.
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Member of SPRC
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Jan 2013 - Dec 2013
Development and evaluation of swabbing technique for cleaning validation using TOC analyzer. Perform Gage R & R to determine conductivity for cocoa tablet, tablet weight, thickness and hardness. Work with professor to prepare process validation plan and cleaning validation. Knowledge of how to prepare and maintain laboratory logbook.Generation of SOP. Development and evaluation of swabbing technique for cleaning validation using TOC analyzer. Perform Gage R & R to determine conductivity for cocoa tablet, tablet weight, thickness and hardness. Work with professor to prepare process validation plan and cleaning validation. Knowledge of how to prepare and maintain laboratory logbook.Generation of SOP.
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Sidmak Laboratories (I) Pvt. Ltd.
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Trainee
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May 2010 - Jul 2011
Formulation procedure, blending, granulation, sieving, drying, coating, tablet formulation, filling and packaging like blister packaging and bottle packaging.Training experience in using HPLC, UV-Vis spectroscopy, TLC,pH meter and analytic balance. Quality controls, Quality Assurance and maintenance of record Formulation procedure, blending, granulation, sieving, drying, coating, tablet formulation, filling and packaging like blister packaging and bottle packaging.Training experience in using HPLC, UV-Vis spectroscopy, TLC,pH meter and analytic balance. Quality controls, Quality Assurance and maintenance of record
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Education
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2013 - 2014
Stevens Institute of Technology
Master of Science (M.S.), Pharmaceutical Manufacturing
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