Tushar Khatri
@tusharkhatri
Bioanalytical group leader with 15+ years delivering GLP/ICH-compliant LC-MS/MS data and mentoring high-performing teams.
IndiaWhat I'm looking for
I’m a result-driven Bioanalytical group leader with 15+ years of experience managing scientific teams and delivering high-quality bioanalytical data to support discovery, preclinical, and clinical programs. I specialize in LC-MS/MS (Sciex and Shimadzu), PK/PD analysis, and regulated bioanalytical method development and method validation aligned with FDA/EMA expectations.
I lead end-to-end bioanalytical workflows—from laboratory setup and capacity planning to method development, ICH M10 validation (selectivity, sensitivity, carryover, matrix effects, accuracy, precision, stability, and robustness), and GLP/GCP documentation for audit readiness. I’m known for strengthening data integrity using ALCOA+++ principles, driving assay innovation through reliable platforms and workflows, and coordinating cross-functional collaborations while mentoring high-performing teams.
Experience
Work history, roles, and key accomplishments
Group Leader, Bioanalysis
Sycon Clinical Research Pvt Ltd
Jul 2024 - Present (1 year 11 months)
Led bioanalytical teams and coordinated cross-functional activities to deliver GLP/ICH-compliant LC-MS/MS method development, validation, and sample data reporting. Oversaw data integrity, protocol/report preparation for regulatory submissions, and audit readiness.
Clinical Manager
Veeda Clinical Research Pvt Ltd
Jan 2023 - Jul 2024 (1 year 6 months)
Managed bioanalytical analysts and supervised GLP/ICH-guided method development, validation, sample processing, and data interpretation. Ensured accurate bioanalytical reporting and quality-system compliance for clinical studies.
Assistant Manager
Cliantha Research Centre
Nov 2021 - Dec 2022 (1 year 1 month)
Supported document verification aligned to experiment design and handled maintenance and calibration planning for laboratory activities. Guided junior staff, resolved day-to-day team conflicts, and delegated tasks to improve group productivity.
Research Scientist
Lambda Therapeutic Research
Jan 2017 - Oct 2021 (4 years 9 months)
Performed bioanalytical method development and method validation, including low-sensitivity assays (e.g., pg/mL) and work on endogenous and complex matrices. Conducted QC checks, maintained instrument calibration, and developed SOPs and validation plans; mentored junior scientists on safety and core lab techniques.
Assistant Manager (Team Lead)
Zydus-Cadila Ltd
Oct 2016 - Jan 2017 (3 months)
Led team activities supporting instrument calibration and maintenance, and produced study-data reports for regulatory submission. Responded to QA queries and updated procedures to reflect regulatory requirements.
Senior Research Associate
Veeda Clinical Research Pvt Ltd
Dec 2010 - Oct 2016 (5 years 10 months)
Led bioanalytical method development, method validation, and project sample analysis for generic molecules using Shimadzu LCMS-8050 and SCIEX API series platforms. Operated and calibrated instruments, reviewed protocols/SOPs, and analyzed GLP/GCP study data with a focus on safety and quality systems.
Education
Degrees, certifications, and relevant coursework
Tushar hasn't added their education
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