Mimi Bui Email & Phone Number

Florida, United States

Mountain View, California, United States

Specialized CDMO in Cell and Gene Therapy product development, clinical, and commercial manufacturing.In my most recent position, I was accountable for overseeing daily QC department operations, prioritizing analytical and microbiology/environmental monitoring, and stability testing to meet business timelines. I examined quality agreements to verify clarity and compliance with site standards. I collaborated with manufacturing operation, MSAT, PM and QA to facilitate technology transfer process. I oversaw QC lab performance, training, and implemented quality system for GMP/CFR Part 211 compliance, regulatory standards, and site goals. I directed and mentored employees to achieve company standards in productivity, quality, and continuous improvement. Furthermore, I defined goals for QC department and employees, overseeing annual performance evaluations.Here are the achievements from this role:• Achieved decrease in non-conformities, streamlined processes to eliminate non-value-added steps, and successfully implemented cost reduction measures.• Ensured regulatory compliance and client satisfaction by reviewing and approving change control activities. Supported QA and contributed to internal and client audits.• Established QC KPI metrics (OOS/OOT, invalid assay) for quality management review, assessing effectiveness and identifying improvement opportunities.• Closed significant process gap identified in client audit by spearheading project to assess, redesign, and implement efficient QC retains management process. Achieved approval within 30 days, conducted widespread training across all sites, and successfully closed Corrective Action/Preventive Action (CAPA) process ahead of deadline, earning client satisfaction for audit response.

Santa Clara, California, United States

During my tenure as a Senior Manager QC, I implemented stability programs, validation procedures, and quality control processes for Rebus Biosystem, contributing to establishment and operational efficiency of startup. I headed overall activities associated with product transfer, such as defining testing methods and specifications for crucial reagents on Esper spatial omics platform in conjunction with R&D development team.The contribution from this role was:• Established and qualified QC lab equipment and materials for product readiness within a short timeline.

Fremont, California, United States

As a Quality Control Manager, I monitored QC personnel and laboratory operations for raw materials, reference standards and final Immunoassay products (Drug of Abuse/Therapeutic Drug Monitoring Reagent, Calibrator, and Control) release testing. I conducted daily stand-up meetings to prioritize timelines, delegate responsibilities, and address conflicts. I teamed up with cross-functional teams to investigate product performance, assess OOS, and implement corrective actions in response to customer complaints and inquiries. I facilitated technical filings and product registration with US/International regulatory agencies. I built QC SOPs/protocols, generated data reports, and effectively managed lot historical and stability database. Moreover, I engaged in internal, ISO, and customer audits, ensuring adherence to ISO 13485 processes.The values delivered in this role were:• Spearheaded continual improvements in QC, ensuring compliance with QSR/ISO regulations, cGMP, and site goals.• Oversaw stability program for finished products and Reference materials, enabling product shelf-life date extensions and minimizing inventory scrap.• Contributed to successful new product transfers into production, met launch timelines, and coordinated stability activities.

Fremont, California, United States

In this role, I led stability group, offering quality assurance support and technical expertise to internal departments and customers, ensuring product claims compliance with company standards.A small selection of highlights from this role:• Revitalized Stability monitoring testing in QC department by overhauling procedures, leading to 30% reduction in materials, time, and labor costs. Allowed QC personnel to engage in skill development, special projects, and additional training, fostering professional growth and career development.• Facilitated date extension requests from customers to prevent scrapping of high inventory, garnering positive feedback.