- Execute extractables and leachables studies for pharmaceutical packaging materials, process contact materials, and device components.
- Perform sample preparation, extraction studies, and analytical testing as per study protocols.
- Support identification and characterization of unknown compounds using mass spectrometry techniques.
- Interpret analytical data and generate scientifically sound conclusions.
- Assist in toxicological risk assessment by providing analytical data and impurity profiles.
- Prepare technical reports, study protocols, and regulatory documentation related to E&L; activities.
- Support investigations related to packaging-related impurities and product quality concerns.
Analytical Development
- Develop, optimize, and troubleshoot analytical methods for identification and quantification of organic and inorganic impurities.
- Participate in method qualification, validation, transfer, and verification activities in accordance with ICH and regulatory guidelines.
- Perform root cause investigations and laboratory troubleshooting activities.
- Review raw data, chromatograms, spectra, and laboratory records for compliance and accuracy.
Instrumentation
Hands-on experience and working knowledge of:
- LC-MS/MS
- GC-MS
- HPLC/UHPLC
- GC-FID
- FTIR Spectroscopy
- pH Meter and other general laboratory instruments
Compliance & Documentation
- Maintain data integrity and GMP compliance in laboratory operations.
- Prepare and review SOPs, analytical procedures, protocols, and reports.
- Ensure adherence to laboratory safety and quality requirements.
- Support regulatory inspections, audits, and client interactions as required.