Job Summary:
Responsible for analytical method development, technology transfer, stability testing, and routine analysis of MDI, DPI, and Nasal products. Ensures compliance with GLP, GDP, data integrity, and laboratory safety requirements while supporting product development and lifecycle management activities.
Key Responsibilities:
- Develop, optimize, and troubleshoot analytical methods for MDI, DPI, and Nasal products.
- Execute analytical method validation and technology transfer activities.
- Perform routine, release, and stability testing using analytical instruments.
- Conduct calibration, verification, and maintenance of laboratory instruments.
- Prepare and revise SOPs, protocols, specifications, and analytical reports.
- Maintain accurate laboratory documentation and ensure data integrity compliance.
- Manage laboratory consumables, reference standards, and other essential supplies.
- Ensure adherence to GLP, GDP, and laboratory safety requirements.
- Support investigations, OOS/OOT assessments, CAPA, and audit activities.
Qualifications:
- M.Sc. / M.Pharm. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
Technical Skills:
- Hands-on experience with HPLC/UHPLC, GC, UV, FTIR, NGI/ACI, Sprayview , rAPSD and particle size analysis.
- Knowledge of analytical characterization of inhalation and nasal products.
- Familiarity with ICH, USP, EP, and regulatory requirements.
Core Competencies:
- Analytical and problem-solving skills.
- Technical writing and documentation.
- Attention to detail and compliance mindset.
- Effective communication and teamwork.
📌 Associate Scientist (Pune)
🏢 LUPIN
📍 Pune