Senior Research Associate-AD

Be the First to Apply Division Piramal Pharma Solutions Piramal 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-AD Job 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. Sample Analysis Perform analysis of development, stability, qualification, validation, and external customer samples. Ensure timely completion of sample testing while maintaining quality and compliance requirements. Instrument Calibration & Maintenance Perform calibration and performance verification of analytical instruments as per approved calibration schedules. Maintain instrument logbooks and ensure instrument readiness. Coordinate instrument preventive maintenance and troubleshooting activities. Documentation & Data Review Prepare and review: Test Procedures (TP) Standard Test Procedures (STP) Method Development Reports Method Validation Reports Analytical Protocols Investigation Reports Scientific Justifications Review analytical data and laboratory records as a peer reviewer. Ensure accurate documentation in compliance with GDP and Data Integrity requirements. Compliance & Quality Systems Follow cGLP, GMP, GDP, and applicable GxP requirements. Maintain ALCOA+ principles and Data Integrity throughout analytical activities. Participate in internal audits, regulatory inspections, and quality improvement initiatives. Adhere to laboratory SOPs and safety requirements. Standard & Laboratory Management Manage analytical standards, reagents, consumables, and columns. Maintain laboratory housekeeping and hygienic conditions. Ensure proper storage and inventory control of reference standards and chemicals. EHS Responsibilities Use appropriate PPE during laboratory operations. Attend mandatory EHS training programs. Ensure segregation and disposal of laboratory waste as per EHS procedures. Comply with all safety, health, and environmental requirements.