Chanyoung Shin

Novartis, Astellas, and Samsung Bioepis, specializing in analytical development and quantitative test method strategy across the product lifecycle. Experienced in developing, qualifying, and validating quantitative analytical and bioassay test methods - including biomarker, potency, and immunoassay platforms - across diverse modalities (ADCs, cell therapies, biologics, small molecules), and translating early discovery into fit-for-purpose test methods supporting program decision milestones and first-in-human readiness. Proven track record leading multidisciplinary matrix teams, with strong history of CRO/CDMO partnership oversight, critical reagent management, and mentoring bench scientists.

Contributed to regulatory-facing deliverables including CTD documentation and data interpretation supporting analytical study reports and program milestones. A self-starting strategist who picks up on early signals quickly and pushes through to an answer even without knowing it in advance; I already hold U.S. permanent residency as part of a long-planned relocation of my career base to the U.S.

• a plan the recent transition coincided with, rather than caused.

Biomarker Lead at Novartis, Biomedical Research (2025-10 – 2026-03)

• Developed fit-for-purpose biomarker plans for RA/PsA and other immunology programs, supporting target engagement, pathway assessment, exploratory biomarker analysis, and first-in-human readiness.
• Interpreted quantitative biomarker datasets and communicated assay strategy, data interpretation, risks, and recommendations to cross-functional stakeholders.
• Role concluded after a change in reporting line and project scope on the company side, unrelated to performance; the timing coincided with an already-planned relocation of my career base to the U.S.

Senior Researcher (Equivalent: Senior Scientist) at Astellas Pharma Inc., Biomarker Assay Development (2023-05 – 2025-09)

• Led PK/PD and biomarker quantitative assay development across modalities (DAC, ADC, TPD, small molecule, LNP) supporting translational research and non-clinical development for mainly oncology projects.
• Contributed to translational research initiatives aimed at improving clinical study success through quantitative analytical assays and fit-for-purpose biomarker strategies.
• Established quantitative clinical biomarker assays for TPD programs (PBMC-based), enabling deployment and use at overseas CROs.
• Supported assay readiness and deployment through collaboration with (Non-) GLP CRO laboratories.
• Searched, evaluated, and recommended advanced biomarker technologies including human cancer organoids, quantitative single-cell proteomics with high-resolution LC-MS/MS, and spectral / RNA-protein flow cytometry.
• Contributed to cross-functional AI–drug discovery task force initiatives as a biomarker scientist.
• Explored MoA hypotheses using spatial imaging MS to analyze small molecule PK distribution at adrenal glands in monkey.
• Advanced neurological biomarker work using semi-quantitative RNA–protein flow cytometry (15–20 colors) to detect mRNA distribution (LNP) and protein expression.
• Developed a state-of-the-art ADA assay using flow cytometry, achieving 500% sensitivity improvement.
• Supported IND/CTD documentation through LC-MS/MS and LBA/ADA assay development and data packaging contributions.
• Managed and mentored 1–2 bench scientists in quantitative assay development/validation and data analysis.

Senior Researcher (Equivalent: Senior Scientist) at Astellas Pharma Inc., Analytical Research Laboratory (2020-02 – 2023-04)

• Established and led optimized internal procedures for characterization of mAb, ADC, and cell therapy products; supported data packaging for biologics applications.
• Oversaw analytical assay development from discovery through commercial phase; prepared CTD Module 3 documentation with scientific rationale and risk assessments.
• Executed comparability, forced-degradation, stability, and characterization studies; supported tech transfer activities.
• Developed and/or supported potency assays including cell-based assays and immune functional assays (PBMC ADCC, ADCP, CDC), plus impurities assays, PCR assays for gene therapy products, and ultra-high sensitivity assays for cell therapy products.
• PADCEV (ADC, commercial, oncology): Potency SME; supported potency assays (ELISA, CBA) and primary human ADCP assay; managed critical reagents; supported responses to CMC regulatory inquiries; collaborated with Seagen US; reviewed CTD M3; prepared M4 pharmacological data (CDC/ADCC/ADCP, etc.). Managed and led ELISA/cell-based assay validation with 4-5 members of junior/staff scientist
• ASP7517 / ASP0739 (Cell therapy, oncology): supported proliferation, apoptosis, binding ELISA assays; established CQAs; supported process development analysis.
• IMAB362 (mAb, oncology): supported PBMC ADCC assay development/characterization.
• PTZ329 / PTZ522 (mAb, closed, oncology): Potency SME; contributed to MoA elucidation with drug discovery teams; supported Treg cell-based assays (anti-NRP1) and cell-based assays (anti-GITR); led CRO selection/management/oversight and biomarker-related analysis.
• Developed systems for assay automation (binding ELISA).

Scientist, Analytical Development at Samsung Bioepis (2017-04 – 2020-01)

• Led analytical development for binding ELISA, FRET, and cell-based potency assays.
• Managed 3–4 junior scientists as sub-lead for potency group (ELISA development and validation).
• Served as SME for commercially approved products (SB4, SB5); supported CTD documentation and comparability studies for FDA/EMA submissions.
• Designed, planned, and led method development, qualification, and validation for bioassays (ELISA, FRET, cell-based assays), SPR, impurities, flow cytometry assays, high-throughput assays for screening, and partial HPLC/LC-MS exposure.
• Collaborated with Regulatory Affairs, CMC, and MSAT for PPQ/validation runs and tech transfer.
• Authored/reviewed scientific documents (comparability, characterization, CTD, deviations, CAPAs, SOPs, protocols, technical reports).
• Performed statistical analysis (DoE, QbD; Minitab) and worked with relevant software tools including LIMS systems.

Ph.D. in Immunology / Autoimmunity / Ubiquitination – Tokyo Institute of Technology (2013 – 2017)

M.S. in Biotechnology / Toxicology – Yonsei University (2011 – 2013)

B.S. in Food & Biotechnology – Korea University (2002 – 2011)