• Managed the analytical activities for a successful EU submission of the Entresto pediatric formulation. Additional submissions pending for the US, Great Britain, China and Japan. • Interfaced with external partners to lead and monitor outsourcing activities and ensure on time deliverables according to Novartis standards.• Planned and coordinated the transfer of analytical activities to CROs, commercial launch sites and different development sites.• Managed budget and FTE forecast for the assigned projects and tracked these activities on a monthly basis.• Managed all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.• Trained and supervised junior associates in analytical testing.

• Interfaced with external partners to lead and monitor outsourcing activities and ensure on time deliverables according to Novartis standards.• Planned and coordinated the transfer of analytical activities to CROs, commercial launch sites and different development sites.• Managed budget and FTE forecast for the assigned projects and tracked these activities on a monthly basis.• Managed all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.

• Coordinated all analytical activities for projects in my portfolio. These activities included method development for new APIs, intermediates and drug products, methods validation, clinical batch release, data review and registration stability setup and trending.• Conducted systematic laboratory investigations and root cause analysis for non-conformances and deviations (OOSs, OOEs) and completed tasks for remediation of CAPAs.• Authored and reviewed analytical methods, method transfer protocols & reports, stability protocols & reports, validation protocols and reports and qualification of impurities reports.• Co-authored and reviewed CMC sections for IND, IMPD and NDA submission dossier/amendments and served as a key member in health authority response team and provided timely responses to Health Authority questions.• Trained and supervised junior associates in analytical testing.

Analytical development of drug substance and drug product from early to late phase.Setting specificationsWriting Development Stability Reports (DSR)Develop methods, write validation protocols and reports Performed routine and specialized testing as a bench chemist using HPLC, GC, Dissolution apparatus, Titrators, Spectrophotometers, etc.