Analytical method validation of Oncology products

✅Leading a team of 5-8 scientists to develop and validate analytical test procedures for US, EU, and WHO market✅Leading a team in converting current HPLC methods to UPLC for the assay, RS, and Dissolution to increase throughput by 3-5 times. ✅Developed RS method with 30 minutes run time for 35 impurities by UPLC.✅Managing the development of new analytical methods for drug products such as Dissolution (I, II, III), Assay, Related Substances, Residual solvents, etc. by HPLC, UPLC, and GC-HS. ✅Optimized the RRF values for a few unstable and inter-convertible impurities in the finished product✅Managing method transfer to QC for drug products ✅Managing method equivalency study for pharmacopeial methods ✅Successfully resolving method-related queries received from QC for effective and error-free implementation✅Reviewing and approving protocols, reports, investigations, and SOPs ✅Imparting on-job training and providing troubleshooting support on various analytical techniques to the team. ✅Working proactively and collaboratively with cross-functional teams such as Formulation, QA, QC, and Project management to achieve project timelines.

✅Successfully identified the origin of the unknown peaks in Pregabalin for timely submission of FTF product. ✅Identified the unknown impurity present in one of the FTF product, Ticaglore, as per the USFDA's recommendation✅Effectively used inorganic salt (sodium sulfate) to avoid gel formation (resulting in poor recovery) during Pregabalin ER tablets sample preparation✅Developed a particle size method for API by using the Malvern Particle size analyzer, to address bio-equivalence failure. ✅Developed assay and dissolution methods by UPLC for combination drug products with less than 5 min run time to increase productivity.✅Conducted reverse engineering to quantify functional excipients present in reference product by using RI detector.✅Designed a spreadsheet for tracking various activities in stability studies such as sample withdrawal, analysis, review, trend analysis, etc.✅Designed a process to map column lifecycle from its receipt to disposal

✅Analyzed raw material, and finished products in QC by using HPLC, GC, Dissolution, etc.✅Achieved critical separation between known and unknown impurity for related substances in a drug product, which had led to several OOS results in the past✅Analyzed stability samples for submission and annual batches. ✅Completed method transfer for ANDA products ✅Handled OOS, OOT, Incident investigations

✅Handled common instruments such as TOC, HPLC, GC, UV, FTIR, KF, pH meter, Auto-titrator✅Analyzed Raw material, Intermediates, and API for water content, wet analysis, and instrumental analysis✅Developed a titrimetric method for the assay of an intermediate to support process optimization ✅Optimized glassware cleaning procedure to eliminate potential cross-contamination for sensitive techniques such as GC, and TOC