Senior Research Executive

Genvicure Therapeutics; Mumbai; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Genvicure Therapeutics in Mumbai seeks a Senior Research Executive Analytical Development with 8–10 years in pharmaceutical Analytical R&D. You will lead analytical method development, optimization, validation, and support regulatory submissions.

The role covers method transfer, stability studies, troubleshooting, and investigations while collaborating with formulation teams. A strong GLP/data integrity background is essential.

Qualifications

• 8–10 years of experience in pharmaceutical Analytical R&D / Analytical Development.
• B.Pharm / M.Pharm / M.Sc. required.
• Strong knowledge of GLP, data integrity, and regulatory documentation.

Responsibilities

• Develop, optimize, and validate analytical methods for drug products and raw materials.
• Perform analytical testing for OSDs, injectables, and other dosage forms during development and stability studies.
• Conduct method transfer, verification, and troubleshooting activities.
• Perform dissolution profiling, assay, impurity analysis, and related analytical evaluations.
• Support formulation development teams through characterization and analytical investigations.
• Prepare analytical protocols, reports, SOPs, specifications, and technical documentation.
• Ensure compliance with GLP, data integrity requirements, and internal quality systems.
• Participate in OOS, OOT, deviation, and root cause investigations.
• Support regulatory submissions through analytical documentation and technical responses.

Skills

Analytical Method Development

Method Validation

Method Transfer

Dissolution Testing

Stability Studies

Troubleshooting

Data Integrity

GLP Compliance

Education

B.Pharm

M.Pharm

M.Sc.

Tools

HPLC/UPLC

GC/IC

UV-Vis

FTIR

PSD

Karl Fischer

Job description

Senior Research Executive Analytical Development

Experience: 8-10 Years

Education: B.Pharm / M.Pharm / M.Sc.

Department: Analytical Development / R&D

Employment Type: Full-Time

Role Summary

We are looking for an experienced Sr. Research Executive Analytical Development with 8–10 years of experience in pharmaceutical Analytical R&D / Analytical Development.

The candidate will be responsible for analytical method development, optimization, validation, method transfer, stability studies, troubleshooting, and analytical investigations for pharmaceutical products.

Key Responsibilities :

• Develop, optimize, and validate analytical methods for pharmaceutical drug products and raw materials.
• Perform analytical testing for OSDs, injectables, and other dosage forms during development and stability studies.
• Conduct method transfer, verification, and troubleshooting activities.
• Perform dissolution profiling, assay, impurity analysis, and related analytical evaluations.
• Support formulation development teams through characterization and analytical investigations.
• Prepare analytical protocols, reports, SOPs, specifications, and technical documentation.
• Ensure compliance with GLP, data integrity requirements, and internal quality systems.
• Participate in OOS, OOT, deviation, and root cause investigations.
• Support regulatory submissions through analytical documentation and technical responses.

Technical Expertise

• HPLC / UPLC
• GC / IC
• Analytical Method Development & Optimization
• Analytical Method Validation
• Method Transfer & Verification
• Dissolution Testing & Profiling
• Assay & Related Substances / Impurity Analysis
• Stability Studies
• UV-Visible Spectroscopy
• FTIR
• Particle Size Distribution (PSD)
• Karl Fischer Titration
• Potentiometric Titration
• OOS / OOT / Deviation Investigations
• Root Cause Analysis
• GLP Documentation
• Data Integrity Compliance
• Analytical Troubleshooting
• Regulatory Analytical Documentation

Preferred Background

Candidates currently working in Analytical R&D (AR&D), Analytical Development (ADL), Formulation R&D Analytical, Product Development Analytical, or Pharmaceutical R&D laboratories with experience supporting regulated pharmaceutical products will be preferred.