Hiring Research Scientists with 7-10 years of experience in Analytical Method Development at Mumbai.
Qualifications: M.Sc / M.Pharma
Requirements :
- Proficient in analytical method development and qualifications, particularly in injectables and Ophthalmic fields
- Hands-on experience with HPLC (Empower and Chromeleon 7.2 software), GC, UV-Spectrophotometer, and other analytical instruments
- Conduct routine analysis and provide analytical support
- Skilled in troubleshooting analytical issues
- Perform Pre-Analytical methods validation
- Experience in diluent compatibility and compatibility studies for Injectables, Ophthalmic, and liquid oral drug products
- Previous exposure to reverse engineering for drug product characterization
Responsibilities :
Develop and validate analytical methods (HPLC, GC, UV, Dissolution, etc.) for raw materials, intermediates, APIs, and finished dosage forms.
Ensure compliance with regulatory guidelines such as ICH, FDA, and other global pharmacopeias during method development and validation.
Troubleshoot and optimize existing methods to improve accuracy, sensitivity, robustness, and reproducibility.
Perform routine and non-routine analysis to support formulation development, stability studies, and process validation.
Prepare technical documents such as method validation protocols/reports, method SOPs, and analytical sections for regulatory submissions (e.g., ANDA, DMF, CTD).
Conduct forced degradation and impurity profiling studies to support product development.
Collaborate with cross-functional teams including formulation, QA/QC, regulatory affairs, and manufacturing.
Review analytical data and ensure proper documentation in line with cGMP and GLP requirements.
Train and mentor junior analysts/scientists within the department.
Maintain and calibrate analytical instruments and ensure smooth lab operations in compliance with safety and quality standards.
To apply, send your resume to jobs.hr@ipca.com