20 Aug
|
Genvicure Therapeutics
|
Mumbai
20 Aug
Genvicure Therapeutics
Mumbai
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.
📌 Senior Research Executive (Mumbai)
🏢 Genvicure Therapeutics
📍 Mumbai