Edward Chu
Director Of Operations
Summary
Accomplished operations executive with over 20 years of experience in the biotechnology and medical diagnostics industries. Proven expertise in driving operational excellence, managing cross-functional teams, and implementing strategic initiatives that enhance productivity and profitability. Strong background in regulatory compliance, product development, and lean manufacturing methodologies. Committed to fostering a culture of continuous improvement and innovation to meet organizational goals. Forward-thinking team leader skilled at operating departments efficiently to meet goals. Successful background matching employees with roles for maximum performance. Proactive and hardworking individual focused on continuous operational improvement.
Overview
23
23
years of professional experience
2
2
years of post-secondary education
Work History
Director of Operations
Sanwa Biotech Limited
9 2019 - Current
- Strategic Leadership: Direct the operational strategy to align with the company's growth objectives, ensuring effective execution of initiatives that enhance performance and market competitiveness
- Operational Optimization: Identify and implement opportunities for process improvements, resulting in increased efficiency and reduced operational costs
- Infrastructure Development: Led the design and construction of a P1/P2 laboratory and an ISO 13485 certified cleanroom, ensuring compliance with industry standards and enhancing R&D capabilities
- Technology Transfer: Successfully managed the transfer of a microfluidic manual production line from Germany to Hong Kong, streamlining production processes and enhancing product offerings
- COVID-19 Response: Established a production line for COVID Rapid tests, meeting urgent market demands while maintaining quality and efficiency
- Financial Management: Oversee financial reporting and analysis, utilizing key performance metrics to drive operational improvements and maximize profitability
- Team Development: Foster a high-performance culture by setting clear goals, providing mentorship, and holding teams accountable for results.
- Defined, implemented, and revised operational policies and guidelines.
- Oversaw daily operations across multiple departments, ensuring seamless coordination and efficient execution of tasks.
- Negotiated with vendors, suppliers and other stakeholders to acquire mutually beneficial contracts and agreement.
- Monitored budget and utilized operational resources.
- Oversaw successful implementation of operational strategies and policies to drive organizational growth and productivity.
- Successfully completed the technology transfer of the microfluidic manual production line from Germany.
- Collaborated with a contractor to design and build an induction sealer and lysis buffer tube sealing machine for the sealing of test kit tubes and lysis buffer tubes.
- Coordinated and aligned various departments within operations, including production, purchasing, warehouse, QC, and QA support, to ensure on-time delivery of COVID Rapid Antigen Tests without any backlog.
- Successfully managed the Building Management System (BMS) of the cleanroom, implementing semi-automatic control that resulted in significant cost savings of HKD 380,000 in electricity compared to the previous year.
- Setup a new ISO 13485 certified warehouse for storage of regulated products and materials.
- Designed and constructed a P1/P2 lab for R&D purposes and a cleanroom (ISO 8, 100,000 classes and ISO 7, 10,000 classes) that meets ISO 14644 standards for the production team.
- Standardized the calculation of Cost of Goods Manufactured (COGM) for finished goods across different departments.
Head of Operations
QIAGEN Shenzhen Company Limited
11.2013 - 09.2019
- Operational Oversight: Managed the operations and manufacturing facilities for In-vitro Diagnostic (IVD) Test Kits, ensuring compliance with CFDA regulations and ISO 13485 quality systems
- Regulatory Compliance: Acted as the company representative for CFDA and ISO 13485, ensuring adherence to quality system requirements and facilitating audits
- Cross-Functional Collaboration: Liaised with global headquarters and subsidiaries to provide technical support and resources, enhancing operational efficiency and product quality
- Market Expansion: Collaborated with headquarters to explore new market opportunities in Africa and South America, contributing to business growth and diversification
- Lean Manufacturing Implementation: Introduced lean manufacturing principles, including 5S and Kaizen, to drive continuous improvement and operational efficiency
- KPI Development: Developed and monitored over 15 key performance indicators (KPIs) to assess daily operations and drive performance improvements.
- Successfully completed the relocation of an IVD certified cleanroom production facility within the allocated budget and timeframe. This new facility includes ISO 8, 100,000 classes and ISO 7, 10,000 classes cleanroom. The total cost of this relocation is over USD 14 million.
- Led the team through a successful onsite audit by the National Medical Products Administration (NMPA) and obtained ISO 13485 certification.
- Led the team through a successful audit by the Brazilian Health Surveillance Agency (ANVISA), enabling the sale of IVD products in their country.
- Led the team through a successful audit by the World Health Organization (WHO), and secured a place on their list of qualified suppliers.
- Led the team in successfully applying and passing ISO 18285 for manicuring forensic-related test kit. This ISO can certify that the facility has the processes in place to minimize the potential of human DNA contamination in the products we produce.
- Effectively transferred the first production line from the headquarters in Germany to Shenzhen, China, resulting in a significant reduction in complaint rates to 3%. Additionally, achieved a 66% financial saving by transferring the production line to China.
- Successfully established and led a local lean team, implementing 5S and lean manufacturing practices at the site.
- Successfully developed over 15 key performance indicators (KPIs) to monitor daily operations, which were fully recognized by the headquarters.
- Improved product’s First Time Right (FTR) and Final Acceptance Rate (FAR) to 98.3% and 99.5% respectively.
- On time delivery of local and overseas sourced materials to factory with average 97.5% and 97.0% respectively.
- Maintained a turnover rate of less than 2% for over three years, demonstrating strong employee retention.
- Effectively controlled inventory value, including raw materials and finished goods, within the target range.
Product & Change Implementation Manager
QIAGEN Shenzhen Company Limited
04.2010 - 11.2013
- Product Change Coordination: Liaised with headquarters and local teams to manage product change requests and new product setups in SAP, ensuring alignment with corporate objectives
- Production Line Transfer: Led the successful transfer of new production lines from Germany to China, enhancing manufacturing capabilities and operational efficiency
- Market Development: Collaborated with sales and marketing teams to explore opportunities in the Southeast Asian market, contributing to revenue growth.
Business Development Manager
Global Power and Energy Company Limited
12.2006 - 03.2010
- Laboratory and R&D Setup: Established a testing laboratory and R&D center, leading a team in the development of technology to convert waste rubber into hydrocarbon fuel
- Grant Acquisition: Successfully obtained grants from the Hong Kong Innovation and Technology Commission for two innovative projects, enhancing the company's research capabilities
- Public Engagement: Organized exhibitions at Hong Kong Park and Eco Expo Asia to promote the company's technology and engage with the public.
Head of Biochemistry
Global Chemicals (China) Company Limited
06.2001 - 03.2006
- Laboratory Establishment: Set up a biochemistry laboratory and managed the production of human epidermal growth factor (hEGF), ensuring compliance with health regulations
- Technology Transfer: Facilitated technology transfer from Hong Kong University of Science and Technology, enhancing the company's R&D capabilities
- Market Exploration: Engaged in market exploration for hEGF sales in Asia, establishing key partnerships and expanding the customer base.
Education
Bachelor of Science in Biochemistry -
Hong Kong University of Science And Technology
Hong Kong 09.1998 - 01.2001
Skills
Operational Management: Strategic planning, process optimization, team leadership, project management
Regulatory Compliance: ISO 13485, CFDA, ANVISA, quality system management
Product Development: Cross-functional collaboration, product lifecycle management, market analysis
Lean Manufacturing: 5S, Kaizen, continuous improvement methodologies
Financial Acumen: Budgeting, cost analysis, financial reporting, KPI development
Languages: Fluent in Cantonese, English, and Mandarin
Technical Proficiency: MS Office Suite (Word, Excel, PowerPoint), SAP, laboratory instruments (UV-Vis, HPLC, GC)
Strategic planning and execution
Strategic Planning
Process Improvements
Operations Oversight
Leadership training
Operational Efficiency
Process Improvement
Cost Control
Risk Mitigation
Quality Assurance
Schedule oversight
Multitasking
References
Available upon request.
Patents
Apparatus and Method for Pyrolysis of Scrap Tyres and the Like (US Patent 8,020,499 B2)
Languages
Chinese (Cantonese)
Native language
English
Advanced
C1
Chinese (Mandarin)
Advanced
C1
Timeline
Head of Operations
QIAGEN Shenzhen Company Limited
11.2013 - 09.2019
Product & Change Implementation Manager
QIAGEN Shenzhen Company Limited
04.2010 - 11.2013
Business Development Manager
Global Power and Energy Company Limited
12.2006 - 03.2010
Head of Biochemistry
Global Chemicals (China) Company Limited
06.2001 - 03.2006
Bachelor of Science in Biochemistry -
Hong Kong University of Science And Technology
09.1998 - 01.2001
Director of Operations
Sanwa Biotech Limited
9 2019 - Current
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