Norristown, Pennsylvania, United States
Experienced professional in the medical device and biotechnology and pharmaceutical industry for 20 years. Skilled in Ligand-Binding Assay, target engagement assay, immunoassay and molecular assay development, clinical research.
• Non-Clinical PK, TK & ADA • LBA qualification and validation • Clinical PK & TE • GLP compliance and documentation • Sample/reagent management and coordination • Bioanalysis lab logistics • Hiring, recruiting and employee merit recognition • Member of AAPS Abstract Screening Committee
• Ligand binding assay reagent qualification, method validation/transfer, clinical bioanalysis for PK and Target Engagement • Maintain, calibrate, and troubleshoot lab equipment/instruments • Conduct lab support and routine maintenance including logbook documentation • Operate laboratory with vigilant quality, safety and compliance standard via GxP practice, SOP maintenance, routine lab self-inspection to ensure lab’s inspection readiness • Manage assigned projects and review deliverables to ensure fulfillment and accuracy prior to submitting to Sponsors/Clients • Establish efficient processes of assay transfer to ensure smooth transition of assays from Client/sponsor to Satellite Laboratory • Proactively monitor project progress to ensure each milestone is met per timeline • Professionally and effectively communicate with sponsors/clients on progress updates, timelines, and issues via emails, teleconferences, instant messages • Coordinate clients/sponsors’ onsite visits and provide needed assistance and cooperation • Ensure lab is well equipped with quality and sufficient supplies, consumables and miscellaneous • Foster cooperative team spirit, and motivate/encourage/lead lab team to maintain positive attitudes and optimism • Recruit/train/mentor new hires to build a productive and dynamic expanding team • Supervise a sample coordination and lab support staff • Acted as a reviewer/screener of biomarkers/assay development/new technologies abstracts for AAPS 2021 Annual Meeting Functioned as an active member of the Company’s Worksite Safety Committee
Biologics Clinical PK Bioanalysis • Ligand-binding assay-based bioanalysis of 5+ blockbuster biologics in Phase 1-3 human clinical trial blood samples in a highly GLP-regulated laboratory • Clinical sample management, bioanalysis, automated liquid handling, reagent management and documentation using Watson LIMS, Hamilton liquid handlers, Mosaic reagent management system, Electronic Notebook, and Cyblab documentation system • Qualified new reagents for ligand-binding assays for clinical bioanalysis uses • Acted as a reviewer/screener of 19 biomarkers/assay development/new technologies abstracts (Regular and late-break) submitted to AAPS 2019 Annual Meeting Functioned as the recorder of the Company’s Worksite Safety Committee Hold a Certificate of Completion for Workplace Safety Committee Training Provided support to obtain the Worksite Safety Committee Certificate issued by the State of PA
Biomarker assay/product development Biomarker clinical research Biomarker asset management Biomarker product technical evaluation and transfer Scientific Exchange of biomarker assay products Scientific support to biomarker assays and products Bioprocess validation for manufacturing
Development of G protein coupling receptor-based cellular and protein-binding assays
Development of G protein couling receptor-based cellular and protein-binding assays
Design and QC of signal transduction pathway gene expression array products (at formerly SuperArray, Inc.)