Executive, Analytical Method Development OSD (GC-MS / E&L)

Extractables & Leachables (E&L)

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.

Education:

B. Pharm B. Pharm - Required

Master Degree (MS/MA) M. Sc. - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: