Regulatory Compliance Quality Control

UMANG PATEL

***************@*****.*** +1-848-***-****

LinkedIn: https://www.linkedin.com/in/umang-patel-78587b1a1 Detail-oriented and skilled bioanalytical professional with experience in chromatography (HPLC, LC- MS/MS), ligand binding assays, and large molecule bioanalysis. Proficient in wet lab workflows, method validation, sample preparation, and regulatory compliance (GLP, cGMP). Strong background in analytical instrumentation, data documentation, and cross-functional teamwork. Adept in molecular biology, including mammalian cell culture and DNA techniques. Skills

• Skilled in using HPLC, UPLC, and LC-MS/MS for analyzing drugs and biomolecules

• Familiar with ligand binding assays and handling biological samples (plasma, serum, etc.)

• Experienced in method validation, sample prep, and working under GLP and cGMP guidelines

• Basic lab skills in PCR, DNA extraction, cloning, and mammalian cell culture

• Comfortable using liquid handling systems and electronic lab notebooks (ELN)

• Good understanding of lab safety, equipment maintenance, and reagent preparation

• Proficient in lab software like Empower, ChemStation, LIMS, and Microsoft Office

• Strong attention to detail with clear communication and team collaboration skills WORK EXPERIENCE

Amneal Pharmaceuticals, New Jersey, USA Jun 2024 – Aug 2024 Quality Control Intern

• Conducted quality testing of raw materials and finished goods, ensuring compliance with cGMP.

• Assisted in managing QC documentation and data recording with 100% accuracy.

• Operated and calibrated analytical instruments, including HPLC and UV-Vis, under supervision.

• Participated in SOP drafting and audit preparation, contributing to compliance readiness. Hetvi Lifescience Pvt. Ltd., Gujarat, India Jun 2022 – Jan 2023 Pharmaceutical Intern (Multi-Departmental)

• Coordinated with cross-functional teams across production, QC, QA, and marketing departments.

• Operated manufacturing equipment for dosage forms including gels, tablets, and suspensions.

• Facilitated SOP development and reviewed QA documentation for procedural consistency.

• Supported product promotion strategies through competitor analysis and marketing research. Accufine Pharmaceuticals Pvt. Ltd., Gujarat, India Jun 2021 – Jul 2021 Pharmaceutical Intern

• Observed and documented workflows in manufacturing, quality assurance, and R&D departments.

• Gained exposure to cross-functional pharmaceutical processes and GMP-based operations. EDUCATION

Master of Science in Pharmacology Sep 2023 – May2025 Long Island University, Brooklyn, NY

GPA: 3.65

Bachelor of Pharmacy (B. Pharm) Sep 2018 – Jun 2022 Institute of Pharmacy, Nirma University, Gujarat, India GPA: 3.4

RESEARCH PROJECTS & THESIS

Bachelor’s Thesis

“The Role of Cosmetic Technology for the Mitigation of Psoriasis” – Nirma University, India.

• Designed and evaluated dermatological formulations for efficacy in reducing psoriatic symptoms.

• Conducted comparative studies on active ingredient release profiles and patient tolerance. Research Program

“Clinical Studies on Drug Utilization of Antibiotics” – Dept. of Experimental and Clinical Pharmacology, Nirma University.

• Analyzed prescription patterns and antibiotic stewardship in clinical settings.

• Presented findings to faculty panel, highlighting misuse trends and recommendations for optimization.

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