ADL - Reverse Engineering Scientist

Job Description

Role & responsibilities Reverse Engineering of Formulations: Perform reverse engineering of reference-listed drugs (RLDs) and identify composition, excipients, and active ingredients . Utilize advanced analytical techniques for component identification and quantification. Analytical Method Development & Validation: Develop and validate HPLC, UPLC, GC, LC-MS, FTIR, UV, NMR, XRD, and DSC methods for comparative studies. Characterize excipients, degradation products, and impurities in formulations. Comparative Dissolution & Physicochemical Characterization: Conduct comparative dissolution profiling with RLD as per regulatory guidelines. Study particle size, polymorphism, stability, and compatibility of drug formulations. Regulatory Compliance & Documentation: Prepare analytical reports, method validation protocols, and regulatory documents for ANDA, USFDA, MHRA, EU-GMP submissions. Ensure compliance with ICH, USP, EP, JP, and WHO guidelines. Technology Transfer & Troubleshooting: Support technology transfer for scale-up and commercialization. Assist in troubleshooting analytical challenges during formulation development . Key Skills & Competencies: Expertise in HPLC /UPLC / GC / LC-MS / FTIR / NMR/ XRD/ DSC Knowledge of polymorphism, solubility, permeability, and excipient compatibility Experience in reverse engineering & impurity profiling Strong understanding of ICH Q2 (R1), USFDA, and regulatory guidelines Hands-on experience in GMP, GLP, and stability studies Preferred candidate profile M. Pharmacy / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry / Organic Chemistry) Perks and benefits As Per Company Policy