Working with CEO directly to build in house CMC organization and capacity including PD, AD, mfg, SC, QC and QA to advance MiNK novel iNKT off-shef cell therapy portfolio growth and expansion.

Built Rubius Cell Therapy Manufacturing Science and Technology function and successfully completed Rubius 1st 200L allogeniec cell product tech transfer into cGMP clinical production.

1. Leading a group of scientists to cover Takeda Autologous and Allogeneic Cell Therapy Drug Product Development from preclinical to BLA. 2. Built Takeda Cell Therapy Drug Product Development team from the scratch including recruiting talents, lab equipment and capacity.3. Built Takeda 1st allogeneic cell cryoproduct closed and scalable vialed product manufacturing process4. Invented a novel cryoformulation, freezing and thawing program for CAR-NKs to achieve comparable in vivo efficacy as fresh cells, resulting in two patent filing

Commercial and Development biologics DP Lead and People Manager to support CMC deliverables­-Served as People Manager to recruit, manage and mentor scientists and contractors to support multiple biologics products­-Led scientists responsible for in-licensed product knowledge transfer, formulation/process/device development gap evaluation and risk assessment, DP fill/finish site evaluation, and tech transfer and onsite fill/finish oversight­-Led scientists responsible for authoring DP related regulatory submissions, performing cross-function review and addressing regulatory inquiries, and collaborating with RA and cross-function team to define filing strategies ­-Led team responsible for commercial product scale-up at CMO including tech transfer, product quality impact assessment and risk mitigation, and onsite oversight ­-Served as investigation lead responsible for critical production and quality investigations, CAPA implementation and production expansion­

Commercial Biologics DP Technical Lead and People Manager to support commercial CMC deliverables­-Led team to ensure consistent CMC support across multiple commercial biologics products including product development and manufacturing process gap analysis, risk assessment and mitigation, scale up, continuous process improvement and global post market commitments­-Led team to serve as a key contact point/interface to address technical challenges/issues with CMOs to support multiple commercial product global supply and expansion­-Led team to apply QbD approach to create commercial process description (CPD), parameter impact assessment (PIA) and process characterization reports for multiple commercial products­-Served as the Quality System owner leading critical DP quality and production investigations to identify root cause(s), CAPAs, and Change Controls to support multiple commercial products global supply and coordinated with RA to file appropriate notices to Health Agencies­-Served as DP Lead accountable for DP related sections to support regulatory filing including IND/IMPD/CTD/JPN/NDA/MAA, briefing books, investigational brochures, label updates and variations, etc., to support process change, global market entry/expansion and address various queries, and performing cross functional review­-Collaborated and coordinated with cross-functional lines (RA, QA/QP, QC, Device, SC, CMO, CRO, DS, Analytical, and PM, etc.) to support commercial CMC team to ensure timely and stable DP global supply

DP Project Lead for a biologics Phase III combination product development with two devices­-Led an international multi-disciplinary team, accountable for Tremfya (Guselkumab) DP development including formulation/process, stability and compatibility with two devices, and manufacturability including down-scale feasibility assessment, scale-up, technical transfer, batch record review, process validation strategy and onsite fill/finish oversight at JNJ commercial manufacturing site ­-Developed downscale models to support Guselkumab scale up and supported a new PFS filling line installation at JNJ commercial manufacturing facility­-Led the efforts to collaborate with global submission Lead to streamline the dossier-centric key documents preparation for formulation/process development, tech transfer protocols/reports, criticality analysis and process master validation plan templates to simplify IND/MAA/CTA/BLA preparation to support global submission ­-Accountable for authoring drug product pharmaceutical development and manufacturing related sections to support regulatory submissions and cross-functional review ­-Accountable for the project drug product resource budget and timely supply of DP to support clinical studies ­-Led research collaboration with University of Kansas in protein oxidation and aggregation, and new tools to visualize protein degradation leading to two publications in peer-reviewed journals

PhRD, NCE and Biotherapeutic Pharmaceutical Science, Specialized in formulation/process development and characterization. tech transfer to support drug product manufacturing, provide technical support for clinical studies, technical and regulatory document preparation