Deepal Patel Email & Phone Number

United States

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

Cambridge, Ma

- 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

Master'S Degree, Biological Sciences (Biotechnology)

Bachelor’S Degree, Microbiology

Postgraduate Degree, Laboratory Technology/Biochemistry

Design Thinking And Innovation

Disruptive Strategies