API Research Analyst

USV; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

USV's Analytical Research Laboratory in India seeks an Analyst (AR&D) to perform analytical testing, method development, validation, and transfer for development, routine and stability batches, ensuring cGMP compliance and data integrity.

The role emphasizes documentation, equipment calibration, and collaboration with QA/QC, Regulatory Affairs, FRD and maintenance teams to deliver reliable data and continuous improvement.

Qualifications

• M.Sc./B.Pharm with relevant pharmacopoeial knowledge and GLP/cGMP awareness.
• Hands-on experience in AMDV, AMT, and method transfer practices.
• Experience with handling OOS/OOT investigations and data integrity.

Responsibilities

• Perform analytical testing for development, routine, and stability batches.
• Develop, validate, and transfer analytical methods as required.
• Maintain documentation, protocols, validation reports, and chromatograms.
• Ensure cGMP, GLP, and HSE compliance during laboratory activities.

Skills

HPLC

UPLC

GC

Dissolution

UV-Vis

Particle Size Analysis

Analytical Method Development

Data Integrity

Education

M.Sc. in Organic/Analytical/General Chemistry

B.Pharm / M.Pharm

Tools

HPLC

UPLC

GC

Dissolution Apparatus

UV-Vis Spectrophotometer

Particle Size Analyzer

Job description

Department Analytical Research Laboratory

Country India

State Maharashtra

Skills

Skill

API Research and Analysis HPLC

Post Graduate

M. Pharm M.Sc.

CERTIFICATION

Working Language

Job Description

Role Objective:

The primary objective of the Analyst (AR&D) is to perform analytical testing, method development, method validation, and analytical method transfer for pharmaceutical development, routine, initial, and stability batches. The candidate will ensure strict adherence to cGMP guidelines, regulatory standards, and HSE (Health, Safety, and Environment) policies, ensuring reliable analytical data reporting and operational efficiency within the laboratory.

KEY RESPONSIBILITIES

1. Analytical Testing & Method Execution

Conduct analytical testing for routine, initial, stability, and development batches.

Perform Analytical Method Development and Validation (AMDV) for tests including Assay, Related Substances, Dissolution, and Particle Size Analysis .

Execute Analytical Method Transfer (AMT) protocols and generate reliable analytical data for regulatory deficiency responses and standard generations.

Conduct literature surveys to support analytical strategy and troubleshoot testing methodologies.

2. Data Management, Documentation & Reporting

Prepare, review, and maintain analytical documentation, including protocols, method validation reports, transfer reports, laboratory notebooks, chromatograms, and calculation sheets.

Ensure immediate submission of raw analytical data to supervisors upon completion of testing.

Promptly report any abnormalities, out-of-trend (OOT), out-of-specification (OOS), out-of-acceptance criteria (OAC) results, incidents, or deviations.

Suggest necessary changes or improvements in analytical methods supported by objective records and evidence.

Execute sample disposal procedures following completed analysis according to standard operating procedures.

3. Equipment Calibration, Maintenance & Compliance

Perform routine calibration of laboratory instruments (e.g., HPLC, Dissolution apparatus, Particle Size Analyzers) and update instrument status boards and logbooks.

Perform HPLC column regeneration as required.

Report instrument breakdowns immediately and maintain complete records of service and repair logs.

Ensure accurate entries in logbooks for the usage of innovator samples, in-house reference standards, working standards, and Pharmacopoeial standards.

Draft, update, and adhere strictly to Standard Operating Procedures (SOPs).

4. Quality, Safety & Continuous Improvement

Maintain strict adherence to current Good Manufacturing Practices (cGMP), GLP, and internal HSE guidelines during all laboratory activities.

Optimize operational costs through economical usage of chemicals, solvents, and laboratory consumables.

Attend all scheduled trainings in accordance with the department training calendar.

Type of Interaction: Internal

Interaction with: AR&D Supervisor/Manager, QA/QC Team, Regulatory Affairs, Formulation Development (FRD) Team, Maintenance/Engineering Team.

Nature of Interaction: Daily reporting of testing progress, submission of analytical raw data, escalation of OOS/OOT results, SOP drafting/reviews, instrument calibration/breakdown reporting, and cross-functional project coordination.

Type of Interaction: External

Interaction with: Analytical Instrument Vendors, Service Engineers, External Reference Standard Suppliers, Regulatory Auditors (during inspections).

Nature of Interaction: Coordination for instrument servicing, preventive maintenance, calibration support, equipment troubleshooting, and demonstrating cGMP/data integrity compliance during audits.

JOB REQUIREMENTS

Professional Experience and Technical Competencies

2 to 5 years of hands-on experience in pharmaceutical Analytical Research & Development (AR&D)

Proficiency in handling analytical techniques and instrumentation: HPLC, UPLC, GC, Dissolution Test Apparatus, UV-Vis Spectrophotometer, Particle Size Analyzer, etc.

Practical expertise in method development, validation, and transfer for Assay, Related Substances, and Dissolution.

In-depth understanding of cGMP, GLP, ICH guidelines, and data integrity principles.

Experience handling laboratory deviations, OOS, OOT, and incident investigations.

Skills & Technical Expertise:

Strong technical writing skills for SOPs, protocols, and validation reports.

High analytical accuracy with a focus on eliminating personal/methodological errors.

Good communication and team collaboration skills.

Academic Qualifications

Educational Qualification: Educational Qualification: M.Sc. in Organic / Analytical / General Chemistry, or B.Pharm / M.Pharm from a recognized university.

Certifications (Preferred): Good Laboratory Practice (GLP) or cGMP compliance training certifications.