Sr. Executive HiMedia Laboratories Pvt. Ltd.

50.0 years

0 Lacs

Thane, Maharashtra, India

On-site

Company Description HiMedia Laboratories Pvt. Ltd. is a global leader in microbiology, cell-culture media and analytical solutions, trusted in 150+ countries for 50 years. Our cutting-edge analytical services division supports biopharma, food & beverage, environmental, and clinical research clients with advanced mass-spectrometry testing. Role Description We are hiring a Sr. Executive – LC-MS & GC-MS Operations to lead day-to-day instrument management, method development, and data review for our high-throughput analytical lab. You will be the go-to technical expert, mentor junior chemists, and ensure ISO/NABL/FDA compliance across projects. 🔑 Key Responsibilities • Method Development & Validation • Design and optimize quantitative/qualitative LC-MS/MS and GC-MS/MS assays (Orbitrap, Triple Quad, Q-TOF). • Prepare validation protocols (ICH Q2 R2, USP <621>). • Instrument Ownership • Daily calibration / tuning, performance checks, preventive maintenance. • Troubleshoot hardware & software issues; liaise with OEM engineers. • Sample & Data Management • Review worklists, run sequences, process data in Xcalibur, MassLynx, Analyst, or equivalent. • Approve raw data, QA/QC charts, and final COA reports. • Regulatory & Compliance • Maintain electronic logbooks, SOPs, and deviation/CAPA records to NABL 17025 & 21 CFR Part 11 standards. • Support internal and external audits. • Team Leadership • Train analysts on sample prep (SPE, QuEChERS, protein precipitation), instrument best-practices, and safety. • Drive continuous improvement and 5S initiatives. 🎓 Qualifications • M.Sc. / M.Tech. / Ph.D. in Analytical Chemistry, Biotechnology, or related field. • 5 + years hands-on LC-MS/MS & GC-MS/MS experience in pharma, CRO, or food/environment labs. • Proven track record in method validation, troubleshooting, and regulatory audits. • Strong grasp of chrom-MS software, LIMS, and data-integrity principles (ALCOA+). • Excellent communication, project-management, and mentoring skills.

Posted 2 weeks ago

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