Scientist, Cell and Gene Therapies, Cell Culture, Assay Development

Kien Tran

************@*****.*** • +1-904-***-**** • LinkedIn • Arlington, MA

No Sponsorship Required

PROFESSIONAL SUMMARY

Ph.D. researcher with 10+ years of experience in cell and gene therapy (CGT) in both academic and industry settings. Specialized in mammalian cell and stem cell research, molecular and developmental biology, upstream and downstream process development. Enhanced iPSC reprogramming efficiency by >100-fold and scale production with AI/automation to process 100s of clones simultaneously. Created multiple disease models (in vitro, ex vivo, in vivo) using CRISPR gene editing. Led 20+ cross-functional projects, driving technology transfer and regulatory documentation. Inventor on 2 patents, author of 4+ publications and 20+ SOPs showcasing innovation and scientific writing expertise. Self-motivated & highly adaptable to drive cross-functional scientific impact. PROFESSIONAL EXPERIENCE

Scientist

Cellino Biotech, Cambridge, MA June 2022 - June 2025 Key Responsibilities:

● Establishing stem cell production workflows from multiple donor sources (blood, immune cells, and fibroblasts).

● Advancing automation platforms for iPSC reprogramming, clonal expansion and differentiation

● Conducting high-throughput purification for early- and late-stage process development, viral clearance, process characterization, and process improvement studies.

● Developing molecular bioassays and implementing automation for high-throughput sample processing.

● Leading cross-functional collaborations among engineers, machine learning, and biologists to develop scalable solutions.

● Contributing to patent assessments & filings and regulatory documentation for scalable cell therapy.

● Leading data analysis and presentations Authoring technical reports and white papers to inform strategic decisions.

● Training and mentoring junior scientists in diverse technologies and supporting daily technical problem-solving. Key Achievements:

● Increased iPSC reprogramming efficiency from T cells by 145-fold and leverage automation to produce 300+ lines annually

(Liquid handlers: TECAN, Hamilton, Zeus; Language: Python), potentially reducing autologous therapy costs by >100X,

● Developed 4 quality control assays (DNA/RNA/protein purification, PCRs, qPCRs, flow, cell-based assays).

● Managed 20+ collaborative projects (experimental design - execution - data analysis - presentations) to provide critical data and 2 regulatory filings for securing a $25M ARPA-H award, partnerships with NEI, Matricef, and MGB, and FDA's AMT designation for scaling up high-quality iPSCs.

● Delivered 30+ technical presentations to team members, C-suite level & external partnerships.

● Trained 6 junior scientists and improved team technical compliance by 30%; authored 15+ SOPs.

● Inventor on 2 patents (iPSC reprogramming & expansion in a closed system & automated laser-based cell management).

● Authored a white paper simplifying complex stem cell bioprocesses for both scientific and non-scientific partners. Researcher

Magee-Womens Research Institute, Pittsburgh, PA March 2018 - May 2022 Key Responsibilities:

● Pioneering a bioprocess workflow for iPSC reprogramming, clonal isolation, expansion & characterization, followed by genome editing and differentiation into targeted cell lineages.

● Handling diverse mammalian cell culture (HEK, N2A, MEF) and primary cell culture (PBMCs, T cells, and fibroblasts), iPSCs, organoids, tissues, mouse and NHP models for various disease modelings and functional assay development.

● Optimizing CRISPR/Cas genome editing and non-viral/viral gene delivery methods.

● Designing & optimized molecular bioassays to characterize engineered cell lines and disease models.

● Conducting CGT research to lead experimental design and execution of preclinical cross-functional studies on patient-derived samples among clinicians and scientists.

● Writing SOPs and regulatory documentation in conjunction with training team members to ensure laboratory compliance. Key Achievements:

● Established an efficient workflow to process 30+ patient-derived iPSC lines for pre-clinical studies.

● Boosted gene delivery efficiency by >5X in mammalian cell lines (HEK, CHO) and human iPSCs.

● Developed 6+ bioanalytical bioassays ((DNA/RNA/Protein purification, PCRs, flow cytometry, qPCR-based genomic screening, immunostaining, SDS-PAGE, ELISA, cell death, cell proliferation, etc.) to support process development.

● Inventor of 3 cell/tissue culture systems (scaffolds, transwells, and hydrogels) to enhance in vitro stem cell differentiation.

● Secured competitive 2-year NIH T32 and 3-year F31 fellowships to advance gene and cell therapies for male fertility.

● Authored 4 peer-reviewed publications and 3 first-authored manuscripts under review to advance CGTs in male fertility.

● Authored 10+ SOPs and multiple regulatory documents, and trained 8 graduate students and 3 medical fellows.

● Delivered 30+ presentations at national/international conferences related to a wide range of topics on improving fertility preservation and restoration in clinical practice. Page 1 of 2

KEY SKILLS & TOOLS

Scientific Expertise

● Mammalian Cell Culture Stem Cell Research Bioanalytical Assay Development & Validation iPSC Reprogramming, Expansion & Differentiation Process development Genome Editing Automation. Professional Skills

● Critical Thinking Cross-Functional Collaboration Project Management Team Leadership Problem-Solving Communication (written & verbal) Mentorship.

Intellectual Property & Technical Writing

● Patent filings Manuscript Preparation & Publication Regulatory Documentation SOPs & Technical Reports. EDUCATION & CERTIFICATIONS

Education

● Ph.D. in Molecular Genetics and Developmental Biology University of Pittsburgh School of Medicine 2017–2022.

● B.S. in Molecular Biology and Biotech University of North Florida 2013–2017. Continuing Professional Development (CPD) Certifications – Alison

● Drug Discovery, Design, and Development.

● Genes and Responsive Drug Delivery Systems.

● Strategic Management-Corporate Strategy.

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