Quality Control Regulatory Compliance

Meghna Patel

California ***** 510-***-**** ***************@*****.*** www.linkedin.com/in/meghna-patel-385428159 USA, Citizen

SCIENTIST

Accomplished Analytical Sciences professional with 20+ years of experience in developing and qualifying assays, leading method transfers, and ensuring regulatory compliance. Proven ability to manage teams and drive process improvements. Demonstrated expertise in ensuring data accuracy, regulatory compliance, and contributing to product development and quality control. Strong background in statistical analysis and cross-functional collaboration to drive innovation and optimize processes.

Areas of Expertise

20+ Yrs. Industry Exp. Ligand Binding PCR/qPCR/ ddPCR Antibody affinity extraction Polymer synthesis Cell Uptake Fluorometer 1D/2D Western Blot Antibody purification D/Q/T Assays Capsid Protein Titer by Octet Bioassay (ELISA) Purification and characterization Dynamic Light Scattering (DLS) Data analysis and instrument troubleshooting Antibody congujation using polymer tags Enzyme Kinetics Assay Flow Cytometry Cell banking Kit based assays HIV-1 based Lenti-Virus Vectors EXPERIENCE

BIOMARIN PHARMACEUTICAL INC.

Technical Scientist 1 -Critical Reagents, 2022 - June 2024 Lifecycle Management of Reference Standards and Critical Reagents Managed the lifecycle of reference standards and critical reagents used in analytical methods for in-process, release, and stability testing across BioMarin’s product portfolio.

Monitored industry trends and implemented best practices to improve efficiency and effectiveness in critical reagent management.

Authored and reviewed Responses to Questions (RTQs) for methods and specifications, ensuring consistency and continuity across analytical sciences teams.

Led lab operations related to critical raw material management. Maintenance of the lab. Method Monitoring, cGMP Compliance, and Continuous Improvement Designed, developed, implemented, maintained, and continuously improved critical reagent management process.

Oversaw and supported the method monitoring program and cGMP operational activities.

Provided technical review and statistical analysis of method performance data to identify trends and potential issues. Led many trouble shooting efforts to keep operations on time. Always led with data driven attitude.

Assisted in change control documentation, reports, deviations, OOS/OOT investigations, and implemented CAPA to ensure flow of quality reagents to testing labs. Most changes backed by documented detailed data analysis.

Authored and owned internal policy documents, SOPs, protocols, and reports for qualification, maintenance, and monitoring of critical reagents and reference standards. Collaboration, Technical Guidance, and Strategic Assessments Collaborated with internal and external partners (Contract Testing Organizations) to ensure proper monitoring of critical reagent supply and analytical method trending data.

Collaborated with quality control lab to ensure compliance with applicable internal and external quality and regulatory requirements.

Provided technical guidance as a subject matter expert to QC and technical laboratory operations teams on method validation/transfer, DOE, study design, etc.

Led the development plans to investigate, troubleshoot, optimize or replace underperforming methods Conducted strategic assessments for new product method transfers, validations, and technology introductions, reviewing progress and approving change requests, protocols, and reports. Meghna Patel ***************@*****.*** Page 2

Senior Research Associate II, 2015- 2022

Assay Development, Qualification, and Transfer

Led the development, qualification, and transfer of cell-based and plate-based assays for various BioMarin initiatives.

Designed, developed, and qualified immunoassays, RP-HPLC and virus-based infectious titer assays for in-process and lot release testing.

Leveraged experience in making agarose polymer gels for purification of natural polymers such as DNA and proteins from mixed population.

Designed and developed Flow cytometery based methods using fluorescence labeled dye for immunophenotyping.

Performed antibody conjugation using polymer tagged antibody.

Developed and drafted relevant and effective QC test procedures, train QC personnel, and set data driven pass / fail specs. Provided scientific insight on transferred assays and oversaw assay performance in the company QC lab.

Cell Line Generation, Banking, and Culture

Became proficient in generating cell banks for insect and mammalian cell lines for AAV and ERT (enzyme replacement therapy) based programs.

Applied experienced in cell culture techniques, including passaging, freezing cell lines, and conducting cell-based screening assays.

Technical Expertise, Leadership, and Collaboration Managed direct reports and mentored research associates within the department by providing hands on training.

Adhered to cGMP guidelines and procedures, escalating non-compliance concerns.

Provided technical expertise on testing, method qualification, transfer, and lifecycle management of critical reagents.

Acted as an interface with other BioMarin departments and contractors and escalated supply risk to appropriate business partners and senior management.

Supported shipment of materials and samples to other BioMarin sites and CROs/CTOs.

Recognized as expert in developing molecular biology and immunochemistry based analytical methods for in- process, release testing and characterization assay (ELISA, Western Blotting, DNA/RNA extraction, serum antibody tittering, etc.)

Demonstrated expertise in preparation of process specific critical reagents using antibodies to monitor host cell protein impurities.

Developed and optimized methods for antibody affinity extraction (using affinity chromatography) tandem with LC/MS-MS for quantitation of antibody percent coverage. Research Associate II, 2009 - 2015

Performed book keeping, burn rate calculations and preparation of critical reagents in-house.

Provided reagents to cross functional departments to support lot release of various commercial products.

Optimized a transgene expression assay to measure transduction potency in liver carcinoma cells (HepG2) using Adeno-Associated Virus (AAV) for Hemophilia A gene therapy.

Efficiently documented test methods and results in ELN.

Prepared and maintained analytical test cell banks as a group lead.

Conducted data analysis and interpretation of results obtained using spectroscopic instrumentation such as DLS HPLC, fluorimeter, and A280 and flowcytometery reader.

Experienced with cell biological techniques including passaging and freezing of cell-lines, ability to drive cell- based screening assays using biochemical, immunostaining or flow cytometry-based endpoints.

Tracked and maintained lab equipment for calibration needs.

Trained Research Associates in cell culture process development and manufacturing to perform CHOP ELISA. Meghna Patel ***************@*****.*** Page 3

Research Analyst, 2003 - 2009

Generated various experimental data with accuracy and precision by working with scientists.

Partnered with R&D to bring test methods into Analytical Sciences and modified, when necessary, after determining its feasibility of use in manufacturing and Quality control labs.

Proficient in troubleshooting and decision-making driven by data.

Made reagents and buffers for scientists in R&D group.

Independently performed various human fibroblast cell uptake assays to address company’s several post approval commitment issues such as uptake time, type of readout activity assay versus antigen ELISA.

Performed comparison of different cell lines and use of Inhibitors in fibroblast uptake experiments. EDUCATION

Bachelors of Science (BS) in Cell and Molecular Biology San Francisco State University

Attended Seminars / Training / Presentations

BEBPA Host Cell Protein Workshop.

Troubleshooting and Maintenance of HCPL with Agilent Technologies.

Assay development and Validation Troubleshooting.

Poster Presentation at BEBPA Host Cell protein Conference May 2019: “Evaluation of antibody coverage with a combination of immunoaffinity chromatography and mass spectrometry” by Meghna Patel, Yu Zhou, Riccardo and Sushmita Mimi Roy.

Poster Presentation at ASMS meeting June 2019 “A novel automated LC-MS data processing platform for immunoreactivity assessment of antibodies developed against host cell proteins” by, Meghna Patel, Yu Zhou, Riccardo Staccini, Geuncheol Gil, and Sushmita Mimi Roy. Other Credentials

Experience managing direct reports and developing next-level leaders.

Experience authoring policy documents, SOPs, protocols, and reports for qualification, maintenance, and monitoring of QC critical reagents and reference standards.

Technical knowledge of and experience in cell-based bioassays (such as potency assays), molecular biology (such as qPCR), ELISA, and/or biochemistry.

Experienced in working in cGMP and GMP.

Proven Team leader for assigned projects.

Ability to prioritize, multi-task and work in high pace R&D environment.

Excellent computer proficiency (Microsoft 365, Excel, PowerPoint, SoftMax Pro, Veeva).

Excellent analysis skills from experimental raw data.

Presented and defended data in front of cross-functional audience.

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