Research Scientist Senior

AMIT PATEL

Iselin, NJ-***** 732-***-**** ************@*****.***

SENIOR RESEARCH SCIENTIST

Accomplished Pharmaceutical Senior Research Scientist with extensive expertise in analytical sciences, specializing in method development, validation, and regulatory submissions (NDA & ANDA). Skilled in GC, HPLC/UPLC, and advanced analytical techniques for precise assessment of volatile and non-volatile compounds. Proven track record in leading projects, managing teams, and providing scientific justifications for regulatory compliance. Adept at risk assessment, technical problem-solving, and ensuring adherence to cGMP standards. Known for innovation, strategic decision-making, and cross-functional collaboration. Extensive experience in analytical method development, validation, and regulatory submissions for a wide range of pharmaceutical dosage forms. Committed to creating a culture of excellence, quality, service, and profitability. Driven by a sense of urgency, ownership, and personal accountability committed to personal and professional growth. KEY SKILLS ANALYTICAL INSTRUMENTS AND TECHNIQUES

• Chromatography Techniques: Extensive experience with HPLC, UPLC, and GC for assay, impurity profiling, and residual solvent analysis.

• Spectroscopy Techniques: Skilled in UV-Vis, FTIR, and TOC for material characterization and identification.

• Inhalation & Nasal Spray Testing: Hands-on experience with Sprayview, ADSA, PAWS, and HAM instruments for spray pattern, plume geometry, and droplet size distribution (DSD).

• Dissolution & Stability Studies: Strong background in multi-media dissolution, drug release testing, and long-term stability assessments.

• Physical Characterization: Expertise in particle size analysis (Malvern Spraytec), bulk/tapped density, and water content determination.

KEY SKILLS IN DOSAGE FORMS

:

• Oral Solid Dosage Forms – Tablets, capsules, and extended-release formulations.

• Oral Liquid Dosage Forms – Suspensions and solutions, Development and validation of analytical methods for assay, related substances, and stability studies, ensuring uniformity and dissolution compliance.

• Topical Gels & Creams – Expertise in rheological characterization, viscosity testing, and impurity profiling to ensure consistency and efficacy.

• Suppositories – Analytical method development for content uniformity, dissolution, and thermal stability assessments.

• Nasal Sprays – Including spray pattern analysis, plume geometry, and droplet size distribution.

• API & Excipients – Characterization, impurity profiling, and stability studies. PROFESSIONAL EXPERIENCE

Cosette Pharmaceuticals, S. Plainfield, NJ June 2021 - Present Sr. Research Scientist I, AR&D.

• Lead the development and implementation of critical analytical test methods for NDA and ANDA submissions.

• Oversee method development, validation, and transfer to QC labs for assay, impurities, preservatives, and residual solvents.

• Conduct risk assessments for elemental impurities, residual solvents, and nitrosamines, ensuring regulatory compliance. Serve as the analytical lead, addressing technical challenges, cross-functional inquiries, and FDA regulatory questions.

• Provide scientific justifications for regulatory submissions and internal decision-making.

• Manage and mentor junior scientists, ensuring project efficiency and adherence to timelines.

• Prepare and review SOPs, method development/validation protocols, technical reports, investigation reports, and compliance documents in alignment with cGMP standards. Amit Patel 732-***-**** Page 2

Lupin Somerset, Somerset NJ March 2016 - June 2021 Senior Scientist

• Developed and validated analytical methods for drug products and substances, ensuring compliance with regulatory guidelines.

• Conducted method verification for compendial and non-compendial methods.

• Led method development and validation for physical tests on nasal sprays, including spray pattern, plume geometry, spray content uniformity, and droplet size distribution.

• Utilized advanced analytical techniques such as UPLC, HPLC, GC, UV, KF, particle size analysis, Malvern Spraytec, and more.

• Authored validation protocols, reports, standard test procedures, and specifications.

• Provided analytical support for product development and responded to FDA deficiencies.

• Assisted regulatory affairs with CMC documentation and submissions.

• Successfully transferred analytical procedures across laboratories, ensuring smooth technology transfer. Ohm Laboratories Inc, New Brunswick NJ August 2012 - February 2016 Senior Chemist

• Developed and validated methods for solid dosage forms, oral suspensions, and APIs.

• Optimized and verified client analytical methods for regulatory submissions.

• Conducted various analytical tests, including assay, related substances, BU, CU, and cleaning verification using HPLC, GC, TLC, and UV-Vis spectroscopy.

• Performed stability studies and hold-time studies, compiling reports and COAs for regulatory approval.

• Led testing for extended-release drug products, including multi-media dissolution and stratified sample analysis.

• Investigated OOT and OOS results, identifying root causes and implementing corrective actions.

• Managed projects from exhibit batch testing to stability studies, supporting ANDA submissions.

• Handled controlled substances (Schedule II-IV) in compliance with regulatory requirements. OTHER RELEVANT EXPERIENCE

Aurolife Pharma LLC, Dayton NJ AR&D Chemist

Apicore LLC, Somerset, NJ Research Chemist

EDUCATION

Doctor of Philosophy (Ph.D.) in Chemistry Veer Narmad South Gujarat University, India Master of Philosophy (M.Phil.) in Chemistry Veer Narmad South Gujarat University, India Master of Science (M.S.) in Organic Chemistry Veer Narmad South Gujarat University, India Bachelor of Science (B.S.) in Chemistry B.K.M Science College, Gujarat, India PUBLICATIONS

• “Synthesis and Characterization of Reactive Dyes and Their Application on Various Fibers” A. L. Patel & K. C. Patel. Oriental Journal of Chemistry, Vol. 22(3) 559-564, 2006

• “Synthesis and Characterization and Application of Hot Brand Reactive Dyes on Various Fibers” A. L. Patel & K. C. Patel. Asian Journal of Chemistry, Vol.19, No. 1(2007), 67-76

• “Reactive dyes based on 4,4’-methylene bis-(2,3-dichloro aniline): Their synthesis, characterization and application”. Amit L. Patel & Keshav C. Patel. Colourage, 57(4), 2010, 72-76.

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