Kalpit Patel Email & Phone Number

Petersburg, Virginia, United States

• Analysis of In-process, final products, APIs, Travel Samples and Raw materials by carrying out HPLC analysis, UPLC analysis, GC, Headspace GC, FT-IR, Refractive Index, water content by Karl Fischer testing, pH.
• Executed Protocol Qualification (PQ) on multiple HPLCs to re-instate the systems for regular lab testing.
• Performed Transfer Method Implementation and SOP writing for it as per current requirements.
• Various USP testing and Titration tests on Raw materials to perform Identification and Assay tests.
• Working experience on LC/GC software like Chromeleon, and FT-IR software like Omnic; experience working with a range of equipment found in a lab setting.
• Supported with the Sampling & Microbiological analysis of water samples on-site such as tests for Coliforms, Plate count, TOC, Conductivity, etc.

Waltham, Massachusetts, United States

• Successfully lead two projects as Analytical lead, providing assistance on analytical aspects and helped to maintain the timeline with desired outcomes.
• Experience in small molecules and bench-level routine testing experience.
• Experience doing HPLC, and GC in a GMP setting, Method development and method qualification.
• Experience in ChemStation, Lab Solutions, Empower, experience working with a range of equipment found in a lab setting.
• Responsible for providing accurate and timely testing of in-process, finished products, and stability, to support the production schedule, ensuring the safety and reliability of products produced in compliance with.
• Performed QC testing of in-process, finished products, and stability samples using techniques such as HPLC, GC, wet chemistry techniques, specific gravity, etc. as directed by the supervisor.

United States

• Analysis of In-process, Finished products and Stability samples by carrying out HPLC analysis, UV-VIS Spectrophotometer, FT-IR, IVRT, Method development, dissolution testing, water content by Karl Fischer testing.
• Conducting dissolution testing (Single point and Profile study) and disintegration studies for Topicals, Injectables and suspensions.
• Developed QA skills through mastering the change control process that includes drafting change controls, gathering multiple department signatures, adding addendums, and filling out extensions.
• Testing of cleaning validation samples using UV and HPLC.
• Prepare Stability compilations and make sure that all the stability timelines are maintained properly.
• Successfully completed 1 FDA audit as part of the Quality control team.

Melbourne, Florida Area

• Preparation of nutrient media and Preparation of pure cultures
• Bacterial transformation (Chemical)
• Extraction and Isolation of DNA (DNA miniprep)
• Preparation of reagents and buffers
• Western blotting, Electrophoresis and SDS-PAGE
• Data presentation and Lab report writing

Surat Area, India

• Blood collection from patients and perform biochemical tests of blood and urine
• Perform microbial tests by preparing and analyzing microbial cultures of the blood samples
• Preparation and Microscopic analysis of slides of the blood and urine samples
• A wide range of clinical instruments handling and calibration of them
• Reports preparation from the data collected from the biochemical - microbial tests

Master Of Science (Ms), Biotechnology, 3.2/4

Master Of Science (Msc), Biotechnology