Senior Research Associate-AD

Be the First to Apply Division Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.   This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.   Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.   For more details, please visit : www.piramalpharmasolutions.com Job Title Senior Research Associate-ADJob Description The Senior Research Associate will be responsible for analytical method development, validation, troubleshooting, and routine sample analysis using advanced analytical techniques such as HPLC, LC-MS/MS, GC-MS/MS, ICP-MS, Ion Chromatography (IC), Gas Chromatography (GC), and Circular Dichroism (CD). The role involves Genotoxic Impurity (GTI) analysis, Extractables & Leachables (E&L) studies, impurity characterization, instrument calibration, data review, and preparation of scientific and regulatory documentation while ensuring compliance with cGLP, GMP, GDP, Data Integrity, and EHS requirements.Key Responsibilities Analytical Method Development & Validation Develop, optimize, troubleshoot, and validate analytical methods using HPLC, LC-MS/MS, GC-MS/MS, ICP-MS, IC, GC, and CD. Perform method validation, verification, transfer, and robustness studies in accordance with ICH, USP, EP, and internal guidelines. Prepare method development protocols, reports, and validation documentation. Genotoxic Impurity Analysis Develop and validate sensitive analytical methods for quantification of genotoxic impurities and nitrosamine-related compounds. Conduct routine and project-based analysis using LC-MS/MS, GC-MS/MS, and ICP-MS. Support regulatory submissions through scientific data generation and technical documentation. Extractables & Leachables Studies Execute Extractables and Leachables (E&L) studies for pharmaceutical packaging systems, processing equipment, and medical devices. Perform sample preparation, instrumental analysis, data interpretation, and reporting using LC-MS/MS, GC-MS/MS, HPLC, and ICP-MS. Support toxicological assessment by providing analytical data and impurity characterization. Impurity Identification & Characterization Investigate unknown, degradation, and process-related impurities using LC-MS/MS and complementary analytical techniques. Interpret chromatographic and mass spectral data for structural elucidation. Prepare scientific investigation reports and technical presentations.