Analytical Chemist Method Validation & Compliance
Resume:
Priyank Patel
**** ******* ** ********** ** ***94 Email: ************@*****.*** Cell No: 224-***-****
PROFESSIONAL SUMMARY
Analytical chemist with over 12 years of experience in pharmaceutical and medical device laboratories, specializing in method development, validation, and chemical characterization of raw materials, in-process samples, and finished products. Skilled in LC-MS, HPLC, GC, GC-MS, FTIR, UV spectroscopy, Karl Fischer titration, and dissolution testing, with a strong record of ensuring data integrity, audit readiness, and full compliance with cGMP, GLP, QSR, and FDA/ICH/USP regulations. Experienced in deviation investigation, CAPA, OOS/OOT resolution, and supporting internal and regulatory audits, with a consistent focus on quality, accuracy, and regulatory rigor across the full product lifecycle. And performed joint analysis at client laboratory with their quality personal to meet satisfied criteria of method transfer.
CORE COMPETENCIES
•Analytical Method Development, Validation, and Transfer (USP, ICH, FDA Guidelines)
•HPLC (Agilent, Waters Empower 3, Shimadzu LC Solution), GC-FID, GC-MS, FTIR, UV-Vis Spectroscopy
•Karl Fischer Titration, Dissolution and Disintegration Testing, pH and Viscosity Analysis
•Stability Studies, Forced Degradation Studies, and Raw Material/Finished Product Testing
•Deviation Investigation and OOS/OOL/OOT Documentation and Root Cause Analysis
•cGMP, GLP, QSR, FDA, EU, TGA, ANVISA, and MHRA Regulatory Compliance
•Data Integrity, LIMS Documentation, and Laboratory Notebook Management
•Instrument Qualification, Calibration, Maintenance, and Troubleshooting
•Chemical Characterization and Extractables/Leachable Testing of Polymeric Medical Device Materials
•Cross-Functional Collaboration, Mentoring, and Audit Support
•Technical Report and Protocol Writing for Regulatory Submissions
PROFESSIONAL EXPERIENCE
Quality Lab Associate III Jan 2023 –June 2026
Baxter Healthcare – Round lake, IL
•Conducted critical chemical and physical analyses on raw materials, in-process and final products, and environmental monitoring samples across Baxter manufacturing facilities, working independently with minimal supervision.
•Operated HPLC, FTIR, UV, and GC instrumentation alongside laboratory computer systems to collect, record, and interpret analytical data.
•Performed advanced assays requiring precise analytical technique and applied principles of chemistry and biology to interpret results.
•Maintained data integrity and ensured compliance with company SOPs, FDA, GLP, QSR, and cGMP regulations.
•Investigated deviations and authored exception, OOL, OOS, and OOT documentation.
•Collaborated cross-functionally on teams focused on improving production efficiency, solving problems, and driving cost savings and quality improvements.
•Performed equipment maintenance and calibration, and documented testing in notebooks, controlled documents, and LIMS.
•Trained and mentored junior chemists on instrument operation, SOP adherence, and proper documentation practices, strengthening overall lab compliance.
•Supported internal and external audits by ensuring laboratory records, controlled documents, and instrument logs were accurate, complete, and inspection-ready.
Research Associate II March 2022 –Jan 2023
Baxter Healthcare – Round lake, IL
•Performed chemical characterization and testing to identify polymeric materials and quantify chemical constituents used in medical devices, including IV sets, IV containers, and IV pumps.
•Identified and quantified chemical substances used in medical device manufacturing processes, including processing aids and residues.
•Conducted qualitative and quantitative analysis of additives in polymeric materials using HPLC.
•Generated chemical characterization data used to support extractables and leachable risk assessments for medical device submissions.
•Collaborated with R&D and Quality teams to interpret material composition data and support device material qualification decisions.
Analytical chemist-II May 2020 –March 2022
Deibel Bioscience – Lincolnwood, IL
•Performed raw material terpene extraction testing using GC-MS (Perkin Elmer) and residual solvent analysis using GC-FID (Shimadzu).
•Conducted moisture content testing for multiple APIs and supported method validation for new sample matrices, including gummies and lozenges.
•Participated in departmental internal audits, resolving documentation and instrumentation issues.
•Applied strong time management skills to ensure accurate test documentation, proper technique, and timely reporting of results.
•Demonstrated and validated new analytical methods for emerging product matrices, supporting expansion of testing capabilities for new client samples.
•Troubleshot instrument and software issues independently, minimizing testing downtime and maintaining lab throughput.
Analytical chemist-II Jan 2020 – May 2020
SGS Life Science Services – Lincolnshire, IL
•Performed a range of testing assignments, taking a lead role in advanced and demanding analytical studies.
•Ensured client testing requests were completed within established turnaround time and quality parameters.
•Conducted routine and specialized analytical studies requested by clients.
•Performed biological Samples via LCMS and GCMS.
Research and Development Analytical Chemist-II June 2019 – Nov 2019
Priority, Inc. – Elgin, IL 60123
•Developed new lab-scale formulations and supported method development for suspension, ointment, and liquid oral dosage forms.
•Performed process method validation and verification according to USP-NF and ICH guidelines.
•Authored validation and stability protocols and reports for veterinary dosage forms.
•Operated HPLC (Empower 3, Agilent 1200), pH meter, Karl Fischer, FTIR, and UV spectrophotometer.
•Led method transfer between laboratories and conducted literature review to identify new analytical methods.
Research and Development Analytical Chemist -II
BDR Pharmaceutical International Pvt Ltd. Sep 2014 – Mar 2018
Vadodara (Gotri) India
•Authored analytical test methods, specifications, protocols, reports, and stability study protocols in accordance with FDA, EU, TGA, ICH, ANVISA, and MHRA guidelines.
•Conducted forced degradation studies on newly developed APIs and maintained instrument calibration per SOP, cGMP, and GLP guidelines.
•Worked across solid, semi-solid, and liquid dosage forms, sterile injections, and lyophilized injections.
•Analyzed raw materials and finished products using HPLC, UV spectroscopy, Karl Fischer titration, and dissolution apparatus.
•Performed analytical method development and validation for raw materials and finished products per ICH and FDA guidelines.
•Supported R&D and technology transfer of sterile, lyophilized liposomal dosage forms, antifungal, immunosuppressant, and anti-cancer products.
•Identified and resolved instrument and sample-related discrepancies using structured problem-solving, reducing repeat testing and delays.
Centurion Laboratories Pvt Ltd. Nov 2012 – Feb 2014
Vadodara (Gorwa GIDC) India (Chemist-I)
•Analyzed raw materials and finished products using HPLC, UV spectroscopy, infrared spectroscopy, titration, pH meter, viscometer, dissolution, and disintegration apparatus.
•Supported qualification, calibration, and maintenance of QC instruments and equipment.
•Conducted analytical testing on raw materials and finished products in accordance with company and USP specifications.
EDUCATION
Bachelor of Pharmacy – University of RGUHS (SCS College of Pharmacy), Harpanahalli, Karnataka, India (2006–2010)
Master of Industrial Pharmacy in Quality Assurance – University of RGUHS (SCS College of Pharmacy), Harpanahalli, Karnataka, India (2011–2013)
TECHNICAL SKILLS
•Instrumentation: HPLC (Agilent, Waters Empower 3, Shimadzu LC Solution/Prominence), GC-FID, GC-MS, FTIR, UV-Vis Spectrophotometer (Shimadzu UV1800), Karl Fischer Titrator, LC-MS
•Testing Equipment: USP Dissolution Apparatus (8 & 14 station), Disintegration Test Apparatus, pH Meter, Viscometer
•Software: Microsoft Office, LIMS, Empower 3, LC Solution
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