Vishal Patel

• Led bioanalytical method development for small and large molecules, managing a team of research scientists.
• Designed and executed laboratory projects while ensuring compliance (ICH M10) with regulatory (FDA, EMA) and quality standards.
• Conducted thorough reviews of clinical protocols to align with global business objectives.
• Monitored process improvement initiatives, effectively prioritizing project tasks.
• Reviewed scientific documents, SOPs, and method-definition plans for accuracy.
• Organized client meetings to present project updates and gather feedback.
• Drafted clinical laboratory sample collection manuals for precision and compliance.
• Served as process owner for globally harmonized bioanalytical policies and procedures.

• Developed and executed bioanalytical methods for small and large molecule compounds.
• Documented experimental designs, analyses, and results in e-Lab notebook and LIMS.
• Participated in process improvement initiatives and monitored outcomes effectively.
• Prioritized tasks and managed multiple projects to meet sponsor timelines.
• Engaged in client calls for method feedback, data interpretation, and project updates.
• Authored and reviewed scientific reports, SOPs, and work instructions.
• Collaborated with cross-functional teams to devise research strategies.
• Ensured compliance with regulatory standards across all research activities.

• Trained and mentored scientists on laboratory techniques and safety protocols.
• Participated in client calls to gather feedback on methods and provide project updates.
• Authored and reviewed scientific reports, SOPs, and work instructions for accuracy.
• Executed development of methods for small and large molecule compounds efficiently.
• Managed project timelines and resources to achieve research objectives effectively.
• Prepared comprehensive reports summarizing research results for colleague and management presentations.
• Collaborated in weekly team meetings to discuss project progress and develop solutions.
• Monitored laboratory equipment performance, conducting repairs, calibrations, and preventative maintenance as required.

• Designed and conducted complex experiments in alignment with established scientific protocols.
• Communicated project timelines and troubleshooting issues with clients to maintain transparency.
• Proficiently executed sample cleanup procedures using PPE, SPE, LLE, and SLE techniques.
• Analyzed bioanalytical methods for DMPK, PK, DDI, and Bioequivalence studies.
• Implemented quality control procedures to ensure the integrity of experimental data.
• Managed laboratory inventory and ensured compliance with safety regulations.

• Develop and validate analytical methods using HPLC-MS/MS instrument settings.
• Troubleshoot laboratory methods and equipment, and maintain instrument records.
• Report writing, reviewing, interpretation, and communication of daily scientific results.
• Mentoring fellow scientists.
• Analyzed biological samples using various analytical techniques.
• Conducted experiments to evaluate drug metabolism and pharmacokinetics.
• Managed project timelines to ensure timely completion of research objectives.

• Operate, calibrate, and maintain HPLC/MS/MS instruments (Sciex 4000, 5000, 5500) and Shimadzu and Waters Acquity HPLC/UPLC.
• Purify, separate, and analyze small molecules by applying the appropriate extraction procedure and chromatographic conditions.
• Review and report quality control and analytical data.
• Working per FDA, ICH, SAMHSA, and CAPA regulations.

• Design, develop, and validate new ELISA test kits and analytical methods to ensure accuracy and robustness.
• Analyze and interpret the results of ELISA tests, and provide support for clinical objectives.
• Identify and resolve the issue with performance and equipment to maintain the integrity of the study sample.
• Hands-on experience with robotic instruments and automated liquid handlers (Tecan).
• Analytical data review and report quality control data.

Prepared and dispensed medications in accordance with pharmacy protocols.

• Maintained accurate inventory of pharmaceutical supplies and controlled substances.
• Ensured compliance with regulatory standards and safety procedures.
• Trained new pharmacy technicians on operational procedures and best practices.
• Checked expiration dates on all medications regularly to ensure freshness of product.
• Participated in continuing education programs relevant to pharmacy operations.
• Labeled containers with correct drug name, strength, dosage form and quantity per instructions from pharmacist.
• Assisted pharmacists with preparing and filling prescriptions for patients.
• Prepared intravenous admixtures using aseptic technique under supervision of pharmacist.