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 determination, ROI, NVR, HMA, Specific Rotation, etc. • 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.• ID and other testing on a range of consumables and packaging materials. • Made sure that all the raw materials, final products and consumables timelines are maintained properly.• Successfully completed internal audits and multiple Client/Vendor audits as part of the Quality control team.• Wrote QCR reports to make sure of proper CAPA is implemented. Assisted Supervisor in performing investigations for OOS and MNCRs.• Developed and maintained superb documenting skills according to GLP in the Laboratory notebook and Validated forms.• Peer-reviewed notebooks, logbooks & validated forms and test results generated by other QC team members.• Critically evaluated and interpreted experimental/test result data. Immediately informed the supervisor of issues and assist in the resolution of complex problems.• Maintained and followed all laboratory systems, cGMP, safety and housekeeping requirements.

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 quality and regulatory requirements. • 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. • Maintained up-to-date documentation. Entered all raw data directly into the notebook and promptly calculated all test results. • Write SOPs for the equipment operation and calibration in GMP set-up, Protocols and qualification reports for the method developed in-house.• Peer-reviewed notebooks and test results generated by other QC team members.• Critically evaluated and interpreted experimental data. Immediately informed the supervisor of issues and assisted in the resolution of complex problems.• Maintained laboratory equipment and instrumentation in good working order, following appropriate procedures for usage, clean-up, and maintenance. • Maintained and followed all laboratory systems, GMP, safety and housekeeping requirements.• Attended meetings with clients on projects and present the project progress updates. • Communicated with vendors to order and for maintenance of the required equipment and materials needed to perform the work.

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, density and viscosity determination, pH determination, and Malvern Metasizer particle size 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.• Assisted Supervisor in performing investigations for OOS and OOT.• Write incident reports and make sure that proper CAPA is implemented.• Developed and maintained superb documenting skills. Document all the activities according to GLP in the Laboratory notebook. Trained others in proper documentation skills. • Assist with development of validation protocols and updating existing protocols, perform testing, and write raw data as per cGLP/cGMP regulations and enter data into the electronic system (LIMS).• Developed analytical methods working in conjunction with technical writing and validation groups. Operated and maintained qualified equipment within a cGMP environment.• Supporting R & D studies for the product testing and compliance with the patient safety guidelines.

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