Huihui Yao
Markham
Summary
Experienced scientist with extensive experience in cGMP, ISO 13485 and continuous improvement. Skilled in a wide range of chemistry, biology and analytical techniques. Rigorous adherence to GDP standards. Proven success in driving cross-functional teams to execute. Driven by problem-solving, innovation and on time delivery.
Overview
17
17
years of professional experience
Work History
Product Development Scientist
Standard BioTools
05.2018 - Current
- Lead design verification and validation activities in developing and manufacturing new reagent product for mass cytometry applications
- Leveraged advanced FPLC system to improve product performance and yield and resulted in cost reduction and production process robustness
- Accelerated time-to-market for new products by efficiently managing project timelines and coordinating resources across multiple departments within the organization effectively
- Spearheaded technology transfer initiatives for successful scale-up from laboratory to commercial production, maintaining optimal product quality throughout the transition process.
- Conducted risk assessments on new products or processes to identify potential safety concerns. Updating SOPs and processes as necessary to improve clarity and accuracy.
- Increased efficiency in the development process with thorough documentation of project progress, results, and next steps.
- Presented research findings at industry conferences to showcase company expertise, contributing to brand recognition and potential partnerships.
- Collaborated with cross-functional teams for efficient product development, ensuring seamless integration of design, engineering, and manufacturing efforts.
- Trained junior scientists and new hires on technical, GMP/GDP/GLP, and quality requirements.
Project Manager
Bubl Technology Ltd.
10.2016 - 02.2018
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results following industry standard and safety guidelines
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Provided detailed project status updates to stakeholders and executive management
Project Coordinator
Sulon Technologies Inc.
07.2014 - 10.2016
- Participated in full life cycle product development from concept design to scale-up of a complex opto-electronic system
- Traveled overseas to audit vendors and training partners in validated testing and inspection processes
- Liaised between departments to facilitate communication and keep appropriate parties updated on project developments.
- Kept projects on schedule by managing deadlines and adjusting workflows.
- Assisted in generating legal documents, Intellectual Property writings and office policy
Co-op Student in Regulatory Affairs and Quality Operations
Seneca College of Applied Sciences
01.2014 - 05.2014
- Trained in the Food and Drugs Act and Regulations, the Medical Devices Regulations, cGMP, ISO 13485, 9000, 9001 quality management systems and practices
- General knowledge in ISO 13485 audit practices
- Experienced in writing and managing documentation for quality operations in pharmaceutical environment including SOP, deviation, verification, validation, FMEA
Research Assistant
University of Toronto
01.2008 - 01.2013
- Perform day-to-day analytical chemistry experiments using high resolution mass spectrometers
- Very familiar with the operations, maintenance and trouble shooting of mass spectrometers
- Utilized statistical software for data analysis, generating accurate insights into complex datasets.
- Developed and validated new procedures through design of experiments and statistics
- Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
Education
PhD - Bioanalytical Chemistry
University of Toronto
Toronto, ONBachelor of Science (B.Sc) - Chemistry
University of Toronto
Toronto, ONSkills
- Cytometry Proficiency
- Chromatography Techniques (FPLC)
- Bio-conjugation Techniques
- Proficient in Cellular Staining Methods
- Tissue Culture Techniques
- Advanced Data Analysis
- Proficient in MS Office
Research and Development
- Collaborative Team Member
- Adaptable Learning Capacity
- Problem-Solving Skills
- Detail-Oriented Approach
- Prioritization and Multi-Tasking
- Effective Communication Skills
Personal
Highlightsofskills
Cytometry, Bioconjugation, Cell staining, Cell culture, Analytical method development and validation, Complex data analysis, Chromatography separation, Manufacturing scaling, MS Office suite, Cytobank, Team player, Quick learning ability, Critical thinking, Attention to details, Multi-tasking, Professional communication
Publications
Available upon request
Timeline
Product Development Scientist
Standard BioTools
05.2018 - Current
Project Manager
Bubl Technology Ltd.
10.2016 - 02.2018
Project Coordinator
Sulon Technologies Inc.
07.2014 - 10.2016
Co-op Student in Regulatory Affairs and Quality Operations
Seneca College of Applied Sciences
01.2014 - 05.2014
Research Assistant
University of Toronto
01.2008 - 01.2013
Bachelor of Science (B.Sc) - Chemistry
University of Toronto
PhD - Bioanalytical Chemistry
University of Toronto
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