Daily Planning, sample allotment, verify routine quality control tests in LIMS.Supervise overall laboratory activities.Support laboratory staff with advanced troubleshooting, resolving complex problems and helping with special projects.Responsible for the investigation of laboratory incidents, Out-Of-Specification (OOS) results, deviations and CAPA implementation.Review of Analytical raw data of Finished product/ Semi-finished products, Stability Product in-process stage.Gap identification and implementation of Good Laboratory Practices through impact assessment, risk assessment, CAPA, deviation and change control.Responsible for routine trouble shooting activities.Responsible for review of HPLC to UPLC method transfer to reduce the analytical time (Software – Empower).Review of Stability studies Protocols and stability summary.Review and resolving technical queries raised during analytical method validation/verification/transfer activities & regulatory submissions.Responsible for routine trouble shooting activities.

Sample preparation of In-Process, intermediate and bulk API.Operation and troubleshooting of equipment, instruments and associated software.Review of investigation of OOS and OOT.Testing & reporting of test results of stability samples as per respective specifications and general analytical methods.

In-process reaction mass, Intermediates and bulk API analysis.Analysis of process validation batches and cleaning validation samples.Interpretation of test results by comparing to established specifications.Responsible for routine trouble shooting activities.

Review of Bioanalytical data and make suggestion for Bioanalytical Study plan, Method Validation and SOPs.Review of Master Equipment list for Calibration, Preventive Maintenance and Performance check schedules.Reply to sponsor, Regulatory and QA Audit Queries.

Responsible for routine LC/MS/MS operation and maintenance of API Sciex 4000s.Perform sample cleanup (solid phase, protein precipitation, and liquid/liquid extractions) on various analytical methods.Responsible for performing all analytical pre-study laboratory work including, but not limited to, critical weighing, solution preparations, QC preparations, sample entry and storage, LC/MS/MS set-up and maintenance, Method Qualifications, and all appropriate documentation.Work with a team of Bioanalytical Scientists and Senior Research Scientists to help troubleshoot problems encountered with methodology during method validations and sample analysis. Responsible for tuning and creating acquisition and quantitation methods on LC/MS/MS systems for the start of new Bioanalytical projects.Work with Quality Assurance Unit to answer project audits (in process, scientific notebook, data and reporting of final data.