1. Job purpose

To perform pharmaceutical analytical testing using Liquid Chromatography–Mass Spectrometry (LC-MS/MS), ensuring accurate, reliable and reproducible results in accordance with approved analytical methods, laboratory SOPs, applicable regulatory requirements and quality standards.

2. Roles and responsibilitiesA. LC-MS/MS operation and analysis

- Operate, maintain and troubleshoot LC-MS/MS instruments for pharmaceutical sample analysis.
- Perform qualitative and quantitative analysis of APIs, impurities, degradation products and other pharmaceutical analytes, as applicable.
- Develop familiarity with triple-quadrupole mass spectrometers, MRM transitions and appropriate ionization techniques such as ESI and APCI.
- Optimize chromatographic and mass-spectrometric parameters to achieve suitable sensitivity, selectivity and reproducibility.
- Perform system suitability tests and verify instrument performance before analysis.

B. Sample preparation and method execution

- Prepare pharmaceutical samples, reference standards, calibration standards and quality-control samples.
- Perform extraction, dilution, filtration, centrifugation and other preparation steps according to approved methods.
- Execute analytical procedures for raw materials, finished dosage forms and other assigned samples.
- Maintain traceability of samples, standards, reagents and analytical runs.

C. Method development and validation

- Assist in analytical method development, optimization, verification and validation.
- Evaluate parameters such as specificity, linearity, accuracy, precision, sensitivity, robustness and range, as applicable.
- Establish calibration curves and evaluate quality-control samples.
- Support investigations of unexpected results, carryover, matrix effects and chromatographic interference.

D. Data processing and reporting





- Process chromatographic and mass-spectrometric data using the relevant instrument software.
- Review chromatograms, peak integration, retention times, ion ratios and calibration results, where applicable.
- Calculate concentrations and report results in accordance with approved procedures.
- Maintain complete raw data, audit trails and analytical records.
- Prepare analytical worksheets and draft reports for authorized review.

E. Quality and regulatory compliance

- Follow Good Laboratory Practices (GLP), good documentation practices and applicable data-integrity requirements.
- Work in accordance with approved SOPs and applicable pharmacopoeial or regulatory methods.
- Identify and report out-of-specification (OOS) results, deviations and atypical analytical observations.
- Participate in root-cause investigations, corrective and preventive actions (CAPA), and audits as assigned.
- Ensure compliance with applicable requirements such as ICH Q2(R2), ICH Q14 and relevant pharmacopoeial procedures, where applicable.

F. Instrument maintenance

- Perform routine cleaning, source maintenance and preventive maintenance according to SOPs.
- Monitor LC pumps, autosampler performance, columns, vacuum status and mass-spectrometer response.
- Maintain instrument usage logs, calibration records and maintenance documentation.
- Coordinate with service engineers for major instrument issues.

3. Qualifications and experience

Criteria

Requirement

Education

M.Sc. Analytical Chemistry, Chemistry, Pharmaceutical Chemistry or M.Pharm

Experience





Typically 2–4 years, depending on the designation

Technical expertise

Hands-on LC-MS/MS operation and pharmaceutical analysis

Software

Experience with the relevant LC-MS/MS data acquisition and processing software

Quality systems

GLP, SOPs, data integrity, OOS and analytical documentation

4. Key performance indicators (KPIs)

- Accuracy, precision and reproducibility of analytical results.
- Timely completion of testing within the assigned turnaround time.
- Instrument uptime and effective utilization.
- Compliance with system suitability and quality-control acceptance criteria.
- Low rates of repeat analysis and preventable analytical errors.
- Complete, accurate and audit-ready documentation.
- Timely reporting of deviations and investigation findings.

5. Important technical interview topics

An LC-MS/MS Analyst should be prepared to explain:

- The principle and working of LC-MS/MS.
- Differences between ESI and APCI ionization.
- Q1, Q2 and Q3 functions in a triple-quadrupole mass spectrometer.
- MRM transitions and the difference between precursor and product ions.
- Matrix effects, ion suppression, ion enhancement and carryover.
- Internal standards, particularly secure-isotope-labelled internal standards.
- Calibration curves, LLOQ, LOD, accuracy and precision.
- LC-MS/MS troubleshooting, including low sensitivity, poor peak shape and unstable response.
- Analytical method validation and verification.
- Handling OOS results and maintaining data integrity.

Note: If this JD is intended for recruitment at ITC Labs, the exact instrument model, product-testing scope, qualification criteria and years of experience should be confirmed against the specific vacancy.

Pay: ₹30,000.00 - ₹50,000.00 per month

Benefits:

- Provident Fund

Work Location: In person

📌 LCMS Analyst (Panchkula)
🏢 ITC_Labs
📍 Panchkula