Scientist – Analytical Chemistry

YONTUS Life Sciences Pvt Ltd.; Guntur District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

YONTUS Life Sciences Pvt Ltd is seeking an analytical chemist to join a regulated laboratory. You will lead method development and validation using HPLC, GC, LC-MS/MS, and related techniques, ensuring compliance with ICH Q2 and GLP.

You will support QA and client projects across pesticides, heavy metals, mycotoxins, and nutraceuticals. You will maintain IQ/OQ/PQ, assist in CAPAs, author SOPs and reports, review data, and mentor junior staff while upholding data integrity per 21 CFR Part 11.

Qualifications

• Hands-on expertise in method development and validation per ICH Q2(R1).
• Exposure to ISO/IEC 17025:2017 and GLP documentation.
• Working knowledge of pharmacopoeial methods (IP, BP, USP, EP).
• Familiarity with LIMS, Empower, OpenLAB, Chromeleon or MassHunter.
• Understanding of measurement uncertainty and method transfer protocols.

Responsibilities

• Execute routine and complex analyses on HPLC, UPLC, GC, GC-MS, LC-MS/MS, ICP-MS, AAS, FTIR and UV-Vis.
• Develop and validate analytical methods for new matrices and clients.
• Perform pesticide multi-residue analysis (QuEChERS), heavy metals, mycotoxins and nutritional parameters.
• Conduct dissolution, assay, related substances and stability studies for pharma clients.
• Maintain instrument qualification (IQ/OQ/PQ), calibration and preventive maintenance records.
• Investigate OOS and OOT results and prepare CAPA.
• Prepare SOPs, validation protocols, reports and certificates of analysis.
• Review raw data, chromatograms and second-person verifications.
• Mentor junior analysts and trainees on instrumentation and good documentation practice.
• Participate in proficiency testing (PT) and inter-laboratory comparison studies.

Skills

Chromatography

Mass spectrometry

Method validation

Pharmacopoeial testing

Data integrity (21 CFR 11)

CAPA

Education

M.Sc./M.Pharm/Ph.D. in Analytical Chemistry or related

Tools

LIMS

Empower

OpenLAB

Chromeleon or MassHunter

Job description

• Execute routine and complex analyses on HPLC, UPLC, GC, GC-MS, LC-MS/MS, ICP-MS, AAS, FTIR and UV-Vis
• Develop and validate analytical methods for new matrices and clients
• Perform pesticide multi-residue analysis (QuEChERS), heavy metals, mycotoxins and nutritional parameters
• Conduct dissolution, assay, related substances and stability studies for pharma clients
• Maintain instrument qualification (IQ/OQ/PQ), calibration and preventive maintenance records
• Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results and prepare CAPA
• Prepare SOPs, validation protocols, reports and certificates of analysis
• Review raw data, chromatograms and second-person verifications
• Mentor junior analysts and trainees on instrumentation and good documentation practice
• Participate in proficiency testing (PT) and inter-laboratory comparison studies

Qualifications & Experience

• M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Analysis or related discipline
• Hands-on expertise in method development and validation per ICH Q2(R1)
• Exposure to ISO/IEC 17025:2017 and GLP documentation
• Working knowledge of pharmacopoeial methods (IP, BP, USP, EP)
• Familiarity with LIMS, Empower, OpenLAB, Chromeleon or MassHunter
• Understanding of measurement uncertainty and method transfer protocols

Core Skills We Look For

Chromatography & mass spectrometry Method validation (ICH Q2) Pharmacopoeial testing (IP/BP/USP) LIMS & electronic data integrity (21 CFR Part 11) Root cause analysis & CAPA

Nice to Have

• Experience with extractables & leachables (E&L) studies
• Exposure to elemental impurities per ICH Q3D
• Publications in peer-reviewed analytical journals

What You'll Learn at YONTUS

• Advanced LC-MS/MS and ICP-MS applications across regulated industries
• End-to-end method lifecycle from scoping to client validation
• Leadership of complex client investigations and regulatory audits

YONTUS Life Sciences is an equal-opportunity employer. We welcome applications from women, persons with disabilities and candidates from underrepresented backgrounds.