Highlights of Key R&R in QC (2012 to 2022 in QC):-Team Leadership and collaboration: Led a team of QC managers driving successful CMC strategies for over 14+ programs across various development stages. Close collaboration between multiple functional areas, including Manufacturing, Regulatory, Quality, Formulation and Supply Chain- Vendor Management & Audits: Oversaw and audited cGMP compliance of multiple CMOs/CTOs, review quality agreements, supported program CMO/CTO selection… Show more Highlights of Key R&R in QC (2012 to 2022 in QC):-Team Leadership and collaboration: Led a team of QC managers driving successful CMC strategies for over 14+ programs across various development stages. Close collaboration between multiple functional areas, including Manufacturing, Regulatory, Quality, Formulation and Supply Chain- Vendor Management & Audits: Oversaw and audited cGMP compliance of multiple CMOs/CTOs, review quality agreements, supported program CMO/CTO selection processes (globally), assisted in developing standardized business processes for supplier relationships including RFI/RFP and MSA generations. Contributed to identifying KPIs for annual vendor performance assessments for preferred CTOs to monitor quality, compliance and CTO effectiveness.- Process/System Improvement: Led and participated in multiple functional/cross-functional initiatives for harmonization/integration of processes, process improvements.- Technical Leadership: Served as QC representative on project CMC teams, collaborated in method validation/transfers at vendor sites, and performed technical testing data review for various analytical methods.- Data Management & Reporting: Performed data review and trending using JMP, entered results into QC databases, and generated Certificates of Analysis (CoAs).- Exception Management: Managed and led deviations, atypical results, OOS investigations, and CAPAs in collaboration with cross-functional teams.- Stability Studies & Shelf-Life Extension: Designed and managed stability studies according to ICH guidelines to extend the shelf life of clinical trial drug substances/products.- Reference standard: Manage requalification, performance monitoring of the reference standards/critical materials.- Regulatory Filings: Authored batch analyses and stability sections for regulatory filings (IND, IMPD, BLA, MAA) and responded to agency questions.- Budget Forecasting: Forecast budgets for assigned clinical projects. Show less

Building expertise in QC (2009 to 2021 with increasing level of responsibilities):-Led a team of QC managers driving successful CMC strategies for over 14+ programs across various development stages.- Collaborated with AD for over 60 successful method validations and transfers for drug substance and drug product from development through registration/commercialization to over 20 CMO/CTO sites globally.- Effectively led strategies for design of stability studies, reference… Show more Building expertise in QC (2009 to 2021 with increasing level of responsibilities):-Led a team of QC managers driving successful CMC strategies for over 14+ programs across various development stages.- Collaborated with AD for over 60 successful method validations and transfers for drug substance and drug product from development through registration/commercialization to over 20 CMO/CTO sites globally.- Effectively led strategies for design of stability studies, reference standard management, GMP stability and shelf -life extensions using ICH guidelines (JMP), CTO/CMO management including audits, management of deviations, OOS/OOT/investigations, change controls, implementing corrective actions (CAPAs) in Trackwise. - Managed release and stability testing of drug substances and drug product conducted at CTOs using RP-HPLC, SEC-HPLC, GC, KF-moisture analysis, protein concentration, micro assays, etc.- Managed and performed data reviews, data trending using JMP/Excel and generated Certificates of Analysis (CoAs) in relevant data management systems.- Authored release/stability sections for multiple IND/IMPD/BLA other regulatory filings and effectively liaising with regulatory agencies.- Authored and revised multiple SOPs, specification documents, shelf-life extension justification reports, end of study stability reports. - Managed budget forecasting for QC activities on clinical projects for the team.- Participated in multiple CMO/CTO selection processes.- Led and participated in multiple continuous improvement department/cross-department initiatives (QC training module using concept of design thinking, post packaged ID testing, design of biologics reference standard strategy, harmonization and integration of QC procedure across 3 sites upon Takeda-Shire integration).- Provided strategic direction and leadership in multiple global and local cross-functional initiatives Show less

- Supervised the QC stability group and managed the stability program for three drug substances and drug products.- Served as Quality Control Dept. lead in method validation and transfer activities to CMOs.- Authored method transfer protocols/reports, qualification/validation protocols/reports for drug substance and drug product.- Generated and revised material specifications, CoA for the drug product and drug substances.- Reviewed and trended CTO release and… Show more - Supervised the QC stability group and managed the stability program for three drug substances and drug products.- Served as Quality Control Dept. lead in method validation and transfer activities to CMOs.- Authored method transfer protocols/reports, qualification/validation protocols/reports for drug substance and drug product.- Generated and revised material specifications, CoA for the drug product and drug substances.- Reviewed and trended CTO release and stability data for drug product and drug substances to ensure compliance with cGMP guidelines. - Served as a technical expert on the analytical methods performed at CMOs.- Designed experiments to troubleshoot assay issues at CMOs and assist in resolving these issues.- Reviewed and approved Change Controls, authored deviations and developed/implemented the plans for CAPA in electronic documentation system (Master Control) .- Performed in-process, release and stability testing of drug substances and drug product by using RP-HPLC, SEC-HPLC, GC, FTIR, KF-moisture analysis, USP Activity Assays.- Maintained Quality Control databases, developed new systems and maintained the existing systems for routine standardization in QC lab, drafted equipment SOPs.- Assisted in recruiting new members to the QC group by interviewing potential candidates. Upon hire, provide appropriate training to new personnel. Show less

- Assisted in development of a headspace GC method for quantitation of residual solvents in Drug Substances. Executed the 1st in-house validation protocol and authored the validation report. - Drafted validation protocols, qualification protocols, validation/qualification reports for the testing of drug substances and drug products in Phase III trials.- Performed in-process, release and stability testing of drug substances and drug product by using RP-HPLC, SEC-HPLC, GC, FTIR… Show more - Assisted in development of a headspace GC method for quantitation of residual solvents in Drug Substances. Executed the 1st in-house validation protocol and authored the validation report. - Drafted validation protocols, qualification protocols, validation/qualification reports for the testing of drug substances and drug products in Phase III trials.- Performed in-process, release and stability testing of drug substances and drug product by using RP-HPLC, SEC-HPLC, GC, FTIR, KF-moisture analysis, USP Activity Assays.- Maintained Quality Control databases, developed new systems and maintained the existing systems for routine standardization in QC lab, draft equipment SOPs. Show less