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.
• 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.
• 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.
• 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.
• 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.
• 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 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.
• 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.
• 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.
• 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