Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
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Angel Yuan

Daly City,CA

Summary

Enthusiastic Process Development Engineer with extensive experience in early- and late-stage Cell and Gene Therapy for both autologous and allogeneic products. Skilled at optimizing processes and driving projects to successful outcomes through strategic planning and goal-oriented execution. Recognized for exceptional time management, adaptability, effective multitasking, and a proactive approach to challenges.

Overview

6
6
years of professional experience

Work History

Process Development Engineer

CARGO Therapeutics
05.2023 - Current
  • Spearhead preclinical development of internal allogeneic CAR-T cell therapy program, leveraging novel vector-based transduction platform. Responsibilities include designing and executing proof-of-concept studies, optimizing cell expansion, transduction efficiency, product purity, and donor selection criteria to ensure consistency and therapeutic potential. Develop and refine scalable manufacturing processes for clinical transition, conduct equipment screening to enhance process efficiency and product quality, and collaborate with cross-functional teams to translate preclinical findings into robust, IND-enabling manufacturing process.
  • Oversee comprehensive project management for preclinical studies, ensuring effective coordination of timelines, deliverables, and cross-functional activities with strategic partners. Lead study design discussions to establish robust experimental frameworks, facilitate data review processes, and troubleshoot experimental challenges to maintain project momentum. Present critical data and insights to internal leadership, enabling informed strategic decision-making and efficient program advancement.
  • Spearhead BLA-enabling process development activities for late-stage autologous CAR-T cell therapy product, managing both internal and external efforts. Responsibilities include Close Container Integrity Testing (CCIT), stability studies, impurity analysis, extractables and leachables testing, and overseeing CROs and CDMOs to ensure quality and adherence to guidelines through inspection of completed and ongoing work.
  • Lead process characterization efforts, including pFMEA, experimental design (DOE), risk assessment, change control studies, analytical analysis, and authoring technical documents. Proactively facilitate cross-functional collaborations, organize and present data to key stakeholders, senior management, and external partners, and participate in strategic decision-making.
  • Support technology transfer to CDMO partners by authoring technical documentation and leading meetings as internal subject matter expert (SME). Responsibilities include planning recovery strategies, troubleshooting protocols, managing supply chain logistics, and guiding personnel to ensure project progression.
  • Serve as CMC Administrator for internal LIMS and ELN systems, including data lake buildout, creation of sample tracking systems, and leading external communications.

Scientist (Process Development)

Graphite Bio
03.2021 - 05.2023
  • Optimized complex gene correction platform (Nula-Cel), transitioning from open to fully closed manufacturing system. This change significantly improved process efficiency, product efficacy, and manufacturing consistency, making platform commercially viable and versatile.
  • Directed cross-functional teams in designing and executing experiments for producing drug products for in-vivo studies and analytical development. Oversaw cell selection from mobilized leukopaks using CliniMACS, cell culture in G-Rex system, in-process monitoring with Sysmex, NucleoCounter, and Cellometer, and cell washing and concentration using CTS Rotea. Managed electroporation and transduction with MaxCyte Flow system, as well as harvest, formulation, and cryopreservation of drug products to meet project timelines and quality standards.
  • Led analytical testing for drug product assessment, including multi-color flow cytometry, cell sorting, colony-forming unit assays, ELISA, gDNA extraction and quantification, ddPCR, potency assays, and HPLC. Managed sample preparation and shipment for external genomic analysis at CROs, ensuring data integrity and timely delivery. Analyzed complex data using statistical tools, presenting insights that informed strategic decisions in internal and external meetings.
  • Oversaw process technology transfer to CDMO, authoring technical documents for regulatory filings and serving as SME during weekly meetings with CDMO, CROs, and internal MSAT teams. Drove project progress, managed manufacturing deviations, coordinated supply chain logistics, and aligned all stakeholders to maintain momentum.
  • Led on-site engagements at CDMO, providing process demonstrations and training personnel. Supervised manufacturing pilot and engineering runs in GMP environment, identified process gaps, and collaborated with CDMO team to implement improvements, ensuring seamless integration into commercial manufacturing processes.
  • Simultaneously managed several complex projects, meeting all pertinent milestones.

Research Associate II

Global Blood Therapeutics
06.2018 - 03.2021
  • Supported small molecule discovery projects by developing and performing various screening assays, including cell culture (primary cells, cancer cell lines, and bacteria), cell-based assays, ELISA, flow cytometry, enzymatic assays, gel electrophoresis, western blotting, and HPLC. Contributed to protein synthesis and purification efforts to support high-throughput screening and mechanistic studies.
  • Assisted in in-vivo studies, handling animals and processing mouse samples (spleen, femur, blood, tissue). Conducted multi-color flow cytometry, ELISA, and cell culture, contributing to data generation that informed project direction and study outcomes.
  • Worked closely with CMC team as internal resource for biologics project, contributing to development, qualification, and validation of analytical methods for phase II clinical development. Assisted in designing methods to ensure product consistency and supported quality control strategy.
  • Managed relationships with CROs, participating in weekly meetings, reviewing data reports, and assisting with troubleshooting experimental challenges. Provided on-site support for training and ensuring that external efforts aligned with project expectations.
  • Analyzed and presented data in project team meetings, providing insights that supported strategic decision-making. Contributed to successful launch of Oxbryta, first-of-its-kind tablet for treating Sickle Cell Disease, by ensuring data integrity and aligning research outcomes with program goals.

Education

Master of Science - Biotechnology Enterprise And Entrepreneurship

Johns Hopkins University
Baltimore, MD
01-2026

Bachelor of Science - Pharmaceutical Sciences

University of Michigan - Ann Arbor
Ann Arbor, MI
01-2018

Skills

  • Auto/Allo CAR-T
  • Stem Cell Therapy
  • Cryopreservation
  • Enrichment/Depletion
  • Cell Expansion
  • Flow cytometry and cell sorting
  • JMP (DOE)
  • Electroporation
  • MaxCyte
  • Lonza
  • Rotea
  • CliniMACS Plus
  • CliniMACS Prodigy
  • LOVO
  • CUE
  • FINIA
  • Sysmex
  • G-Rex
  • Alerion
  • DynaCellect
  • CRISPR Cas9
  • AAV
  • Lentivirus
  • ImageStream
  • PCR
  • ddPCR
  • ELISA
  • Western blot
  • Immunohistochemistry
  • Benchling
  • GMP/GLP
  • SQL
  • ZPL

Accomplishments

    Patent Pending: Methods for Clinical-Scale Production of Genetically Modified Primary Cells. U.S. Patent Application No. 63/505647, filed on June 1, 2023.

Languages

Chinese (Mandarin)
Native or Bilingual

Timeline

Process Development Engineer

CARGO Therapeutics
05.2023 - Current

Scientist (Process Development)

Graphite Bio
03.2021 - 05.2023

Research Associate II

Global Blood Therapeutics
06.2018 - 03.2021

Master of Science - Biotechnology Enterprise And Entrepreneurship

Johns Hopkins University

Bachelor of Science - Pharmaceutical Sciences

University of Michigan - Ann Arbor

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