Experience

• 

  Sangamo biosciences

  Sept 2013 - Jan 2017

  Senior research associate

  ● QA, QC validation of Human and other animal samples● AAV cell-based neutralization assay● Under GMP guidelines perform genomic DNA isolation from HIV infected cells, tissue samples using established SOPs● Performing q-PCR on clinical and manufacturing samples using established SOPs. Submitting results on QA and QC paperwork. ● Writing reports for IND filings

• 

  Orchard therapeutics - u.s.

  Jan 2017 - Aug 2020

  • Oversaw and managed assay development analytical team for qualification/validation and TT to CDMOs and CTLs.• Developed analytical methods on ddPCR, qPCR, CE, flow cytometry, cell-based assays, and ELISA platforms.• Supported the analytics for early, and late-stage product development.• Designed and managed development and validation of analytical methods used for characterization and release testing of viral vectors and cell-based drug products.• Managed assay transfer to internal and external QC labs and provided feedback on release and stability specifications.• Assisted in the preparation of CMC regulatory submissions, including providing data summaries and trend analysis. Show less

  • SeniorScientist, Analytical Lead

    Apr 2020 - Aug 2020

  • Scientist, Analytical Lead at Orchard Therapeutics

    Jul 2018 - Apr 2020

  • Senior Associate, Analytical Operations

    Jan 2017 - Jul 2018
• 

  Kite pharma

  Aug 2020 - Mar 2024

  • Directs a highly technical group of 13 Scientists in developing phase appropriate methods for characterization and release of viral vector and T cell products.• Provides technical leadership on method life cycle activities (development, qualification, validation, and transfer) and for Regulatory filings (IND, BLA Type C) and RTQs.• Fosters collaborations within Process development, Manufacturing, Quality, Regulatory, and Research.• Works with internal partners on developing Analytical control strategies for drug substance and drug product quality attributes.• Provides technical and strategic input to build robust relationships with cross-functionally with Research, Process Development, Quality, Supply Chain, Manufacturing, and CMC Regulatory Affairs Show less • Led a team of scientists on Product and Vector Characterization and Analytical activities in support of vector and engineered immune cell product development• Manage day-to-day analytical activities including timelines, objective setting, and internal lab operations• Ensure standard operating procedures, analytical test methods, and analytical sampling plans met the highest industry standards• Engaged cross-functionally with process development, manufacturing, and Quality to advance vector process development and T cell therapy programs• Developed analytical methods for vector and cell therapy products including process improvements and efficiencies• Participated in authorship, review, and implementation of policies and procedures for existing and future operations to enhance service quality and efficiency• Continuously oversaw the development, implementation, and maintenance of appropriate staff training program to ensure competency and compliance with company values, including staff training and relevant documentation to ensure regulatory compliance• Provided input to develop budget and assured appropriate resourcing of the analytical operations group• Ensured a collaborative work environment with key client groups in Research, Vector and T Cell Process Development, Quality and Manufacturing • Provided strategic, technical, and scientific leadership to a highly technical analytical method development team• Evaluated innovative technologies for use in and/or to advance impurities method development Show less • Conducted PCR and ELISA-based method development activities and method life cycle from conception, development and qualification or validation through method transfer to internal global Quality Control sites and Kite partners• Employed quality by design (QbD), design of experiment (DOE), and statistical approaches to method development to identify robust operating range within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines• Planed, executed, analyzed, and used GDP to document experiments that support routine development activities, innovation, investigations, and project goals• Worked cross functionally with clinical and commercial QC during knowledge, method and tech transfer, and co-qualification/validation• Served as SME and technical advisor on method validation, method transfer, comparability/bridging protocols, regulatory filings, and RTQs• Authored and reviewed accurate technical, development and qualification reports to support regulatory filings• Collaborated closely with other key line functions and communicate complex data/decisions within department and cross functionally• Managed and guided junior level scientists on phase appropriate method development using (QbD), design of experiment (DOE), and statistical approaches Show less

  • Director, Head of Molecular Method Development

    Oct 2022 - Mar 2024

  • Associate Director, Analytical Operations

    Jan 2021 - Nov 2022

  • Sr. Scientist

    Aug 2020 - Jan 2021
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  Sana biotechnology, inc.

  Mar 2024 - now

  Sr. director analytical development