Michelle Huynh

Manufacturing leader with 10+ years in regulated reagent and diagnostics manufacturing, including 5+ years supervising teams responsible for formulation, lyophilization, filling, and packaging in GMP/ISO 13485 environments. Proven track record leading manufacturing planning, capacity forecasting, NPI/PPI technology transfer, validation (IQ/OQ/PQ), and cross-functional troubleshooting with Quality, Engineering, R&D, and Supply Chain. Skilled at translating product demand and technology roadmaps into operational plans, driving yield, throughput, and inspection-readiness through data-based decision-making and continuous improvement (Lean, Kaizen, DBS).

Reagent Manufacturing & Reagent Release Testing Supervisor - Danaher, Cepheid - Sunnyvale, CA

(2012-01 - 2025-12)

Manage Reagent Manufacturing and Release Testing teams responsible for oligo/dye formulation, lyophilized bead manufacturing, filling, and bead/LSP release testing — ensuring on-time delivery, batch record accuracy, and customer satisfaction in a GMP/ISO 13485 environment

• Establish and monitor manufacturing performance metrics (Safety, Quality, Delivery, Inventory, Productivity / QDIP) — drive data-based decisions on yield, throughput, utilization, and deviations through daily management (DM)
• Lead Manufacturing participation in New Product Introduction (NPI) and New Process Introduction (PPI) — partner with R&D, Product Transfer, Quality, and Engineering on layout, process flow, BOMs, costing, and SOPs to ensure manufacturing readiness from development through routine production; serve as Manufacturing SME and Technical Lead
• Maintain and update manufacturing procedures, worksheets, BOMs and general manufacturing SOPs to ensure manufacturing documentation comply with GMP and ISO requirements
• Ensure batch record review readiness and timely completion of manufacturing documentation; review and submit batch records to Quality with 100% accuracy and on-time delivery
• Accomplish manufacturing staff results by communicating clear job expectations; planning; monitoring, and appraising job results; coaching, counseling, disciplining, fostering trust and maintaining employee's accountability; enhancing employee engagement to increase productivity and business growth
• Identify training needs and ensure training plans are created, executed, and documented to maintain qualification readiness per ISO 13485; deliver performance reviews, coaching, and development for team members and new hires
• Monitor team performance – optimizing utilization of personnel and equipment to maximize productivity and overall efficiency
• Represent Reagent Manufacturing in internal and external audits and regulatory inspections; maintain manufacturing areas in an organized, controlled, and continuously inspection-ready state through inspection checklists, walk-throughs, and enforcement of safe work practices
• Execute manufacturing process validation (IQ/OQ/PQ) and validation readiness activities; drive process optimization to improve yield, cycle time, robustness, and quality across multiple product lines
• Acquire and implement new methods, processes, techniques and equipment required for scale-up of manufacturing process
• Lead troubleshooting for manufacturing and equipment issues; coordinate cross-functional resolution with Product Transfer, Quality, and Engineering — perform hands-on laboratory investigations, escalate appropriately, and ensure SOP and training compliance to sustain cost-effective, quality production
• Develop and execute short- and mid-term manufacturing plans aligned with demand forecasts, capacity constraints, and material availability; forecast capacity needs across equipment, staffing, and consumables and recommend capital investments to support product roadmap and growth
• Assist Manufacturing team to apply DBS tools (Danaher Business System tools) in the daily work to drive impactful change and achieve extraordinary results
• Lean Manufacturing Projects – implemented and sustained the manufacturing floor by applying the DBS tools: 5S, DM, PSP, Kaizen, VSM
• Responsible for the smooth production build in Reagent Manufacturing, control the workflow, and provide technical leadership where appropriate
• Planning/ Scheduling/ prioritizing production schedule to optimize the resource and expedite the workflow
• Organize Production Orders with respect to planning and scheduling for multiple products simultaneously in a timely manner
• Collaborate with Planning, Materials, Logistics on the materials/ scheduling issues to ensure OTD of the product and adhere to the build plan
• Drive Material Review Board (MRB) and change-management activities through Agile PLM, SAP, and ERP — author, route, review, and approve DCO, ECO, AWF, and CAPA records impacting manufacturing
• Coordinate working with other departments to ensure the work's transaction flow goes smoothly
• Analyze data using MS Excel macros, evaluate the PCR assay against the specifications and make the decision to move to the next production step
• Execute cycle counts and inventory controls; implement Kanban systems to control raw-material flow between inventory and the manufacturing floor; resolve discrepancies and implement preventative measures
• Participate in a global President Kaizen event to standardize the manufacturing process between Cepheid sites (Solna and Sunnyvale)
• Maintain quality service by establishing and enforcing compliance to organization standards
• Assist in attaining quarterly and annual production goals
• Maintains professional and technical knowledge by attending educational workshops

Bachelor of Science - Biochemistry with minor in Computer Science - University of California, Davis