Junyi Y. Email & Phone Number

West Chester, Pa, Us

North Chicago, Illinois, Us

Expertise in regulated bioanalysis, CRO outsourcing, and assay development using LC/MS and Immuno-LBA techniques within Quantitative, Translational, and ADME Sciences (QTAS).Experienced study monitor for neuroscience and immunology therapeutic toxicology and clinical studies.

North Chicago, Illinois, Us

Cerevel is acquired by AbbVie in Aug2024.• Managed Bioanalytical (BA) CRO for strategic planning and delivery of robust assays.• Led BA method development and technology transfer to US and external CROs.• Oversaw scientific reviews and ensured timely, high-quality data from CROs for GLP and Clinical studies.• Coordinated BA and CRO work timelines in clinical study team meetings.• Reviewed and approved data/reports in collaboration with CRO BA PI and PM.• Collaborated with internal quality and operations teams.• Contributed to IND/BLA document preparation (e.g., IB/NDA sections 2.7.1/2.6.4) and addressed regulatory agency inquiries.• Manage the technical qualification and conduct on-site audits of CROs to ensure compliance and quality.

Brentford, Middlesex, Gb

• Provide bio-analytical assay and operational expertise to clinical study team to ensure timely delivery of PK/target engagement biomarker data.• Provide technical support/outsourcing strategies for selection/qualification/oversight for external bioanalytical CROs. • Serve as Bioanalysis representative in clinical team, with oversight responsibilities for resource and budgetary planning, CRO selection/placement, contracting/invoice approval, bioanalytical assay transfer/validation/sample assay/data release, report generation, regulatory submissions, and QA inspections.• Serve as Bioanalysis representative to interact with GSK nonclinical and clinical study delivery teams (including Clinical Pharmacology, Clinical Biomarker, DMPK, Clinical Operations, Data Management, Regulatory Affairs, and Project Managers) and participate in program related meetings.•Qualify 3 China CROs to grow the GSK's Bioanalytical capacity in China and Led GSK China’s bioanalytical projects, ensuring compliance and collaboration with regulatory agencies such as NMPA/CDE and HGRAC.; Collaborate with GSK internal team to implement new initiatives to transfer and cross-validate PK/TE bioanalytical methods from GSK global to GSK China CROs

Exton, Pa, Us

Lead a BA team to conduct and deliver bioanalytical method development (LC－MS/MS) projects (small molecules/peptides/oligonucleotides)

Exton, Pa, Us

• Method development and validation for small drug molecules/agri-chemicals (pesticides)/large drug molecules in different biological matrics (plasma, tissue, and surrogate matrics) by LC/MS/MS. Developed 40+ bioanalytical methods for PK and PD studies for different clients.• Sample preparation (SPE/PPT/LLE/SLE/DBS) for LC/MS and automation (Tomtec).• Proficient in HPLC separation (reverse phase/normal phase/ion-pair chromatography)• Proficient in protein-drug binding evaluation (ultrafiltration)• Proficient in E-Notebook.• Draft and approve validation documents and test reports for clinical and pre-clinical studies in accordance with FDA Bioanalytical Method Validation guidelines.• Perform role of principal Investigator / responsible scientist as trained and as assigned by management for GLP and Clinical Studies.

Lincoln, Ne, Us

Project1. Synthesize and investigate the effects of nutraceutical compounds on subclinical metabolic disorders and gut microbiota composition using the C57/B6J mouse model2. Synthesize 5-ASA-inulin, a potential prodrug of 5-aminosalicylic acid, and quantify by HPLC/FT-IR3. Analyze dietary fibers, polyphenols, and the anti-cancer drug diosgenin using GC-FID/HPLC4. Profile the metabolic markers (leptin, resistin, MCP-1, TNF-alpha, IL-6, GLP-1, and adiponectin) in HF/fiber-fed C57/B6J mice using MILLIPLEX® multiplex assays5. Design trials on the relationship between gut metabolites, dietary habits, and human (gut) health6. Perform in vitro evaluations of feruloylated arabinoxylooligosaccharides using human feces7. Isolate DNA/RNA for qPCR, gene expression analysis, and Illumina sequencing

Lincoln, Ne, Us

Project：1. Enhanced the application of whole grain/dietary fibers in functional foods by investigating their impacts on gut microbiota from the normal weight and obese using pyrosequencing2. Operated HPLC and GC systems for the analysis of carbohydrates and fatty acids3. Performed biomedical analyses of short- chain fatty acids and ammonia in human feces

Doctor Of Philosophy (Ph.D.), Food Chemistry

Master'S Degree, Food Sicence And Tech