Yiwei M. Email & Phone Number

California, United States

Emeryville, California, United States

San Francisco Bay Area

• Selected, configured and implemented an enterprise-wide electronic Quality Management System (eQMS) software. Rolled out functions include document and record repository, training management, change control, deviation/CAPA, Material Review Board, product compliant, risk assessment, regulatory correspondence. • Delivered digitalized processes and supportive procedures to clinical, regulatory, small molecule and cell therapy CMC teams to improve workflow efficiency. Ensured data integrity.• Overseed filing and maintenance of GxP documentation and records. • Overseed training completion for GxP employees.

• Developed and improved quality system in a risk-based approach. Implemented and mangaged on a daily basis the change control program, training program, deviation/CAPA/OOS program, document and record management, etc.• Responsible for T-cell therapy product and lentivirus product disposition, reviewed manufacturing batch records, QC test records, provided QA review on process development documents (comparability study, stability study, assay qualification, equipment IOPQ).• Responsible for QA oversight of CMO and CRO activites, conducted vendor audits and maintained the audit issue trakcer.• Provided GMP compliance training to the CMC team.

Emeryville, California, United States

Design and implement quality system for cell therapy clinical manufacturing and clinical trial operations, ensure GMP/GLP/GCP compliancy and drive gap analysis

Emeryville, Ca

T-cell and Lentivirus QC Assay development and qualification, quality system design and gap analysis

Hopokinton, Ma

• Cell culture research: o Performed cell culture experiments for commercializing an ancillary cell therapy product, PLUS™ human platelet lysate. Expanded the use of this product to various cell types. o Performed protein and cell-based assays for in vitro and in vivo assessment of multiple wound healing products. • GMP process development: o Working in a team, developed the GMP manufacturing process for Bio-PLUS™ Bandage in an ISO 7 clean room. Wrote and maintained SOPs, work instructions, master batch records, forms and logbook, etc. o Designed and validated a cell-based functionality assay for PLUS™ products characterization and QC release. o Wrote and implemented validation tests for developing a repackaging process of GMP PLUS™ to meet the special needs from customers.• Project management: o Prepared proposals and budgets for bringing multiple contract research and manufacturing services in-house and oversaw successful completion of deliverables within timeline and budget. o Sourced and maintained relationship with outside CMO/CROs for development and characterization of company’s products.• Quality and regulatory: o Responsible for all material management activities including vendor sourcing and qualification, raw material receiving, inspection and releasing, inventory control, etc. o Closely working with Clinical and Regulatory departments, filed a 510k submission to the FDA for Magellan BioBandage™ of chronic wound use.• Clinical research and data analysis: o Developed study protocols, SOPs and Case Report Forms for clinical case studies focused on chronic and burn wound healing utilizing Bio-PLUS™ Bandage. o Performed statistical analysis for a phase I clinical trial of burn wound healing.• Managed laboratory operations. Hired, trained and supervised junior biologists on experiment design, laboratory skills, etc.

Cleveland/Akron, Ohio Area

• Worked in a small research team, developed and optimized NanEXTM, a nanofiber-based culture expansion product for Hematopoietic Stem Cells (HSCs).o Transitioned the manufacturing process of NanEX™ into a commercial scale. Established and implemented QC release criteria. Developed and validated a terminal sterilization method of the product. Launched a new version of product in closed culture bag format. o Designed and performed cell culture experiments to maximize the HSC yield using NanEX™. Provided technical support to customers and optimized the Instructions for Use based on feedback.• Worked as Project Manager in a BARDA-funded pre-clinical and clinical program for development of Magellan BioBandage™ to treat deep partial thickness burn wounds. o Prepare logistics and timeline of animal studies, responsible for minutes taking and action item follow up, coordinated with clinical sites for study protocol development and patients’ sample collection. o Performed hematological and ELISA analyses of porcine blood and Platelet Rich Plasma (PRP) samples to optimize the Magellan treatment. Troubleshot when no reliable ELISA kits were available on the market. • Performed literature search for identification and evaluation of new technologies to be developed or commercialized.

Master Of Science (M.S.), Pharmaceutical Sciences

Bachelor Of Science (B.S.), Biochemistry And Molecular Biology