JEFF DEGUZMAN
San Leandro,CA
Summary
Dynamic Metrology Lead at Lonza Biologics, Inc., skilled in instrument calibration and regulatory compliance. Proven track record in leading teams to enhance operational efficiency and drive continuous improvement. Expertise in 21 CFR Part 11 compliance and project management, fostering cross-functional collaboration to achieve strategic goals.
Overview
27
27
years of professional experience
Work History
METROLOGY LEAD
Lonza Biologics, Inc
Hayward, CA
03.2022 - 02.2025
- Team Leadership & Development: Lead, coach, and manage a metrology team, providing performance feedback, setting objectives, and ensuring proper training on equipment and procedures.
- Calibration & Compliance: Maintain, calibrate, and validate inspection, measurement, and test equipment (IM&TE) in compliance with industry, state, or regulatory standards.
- Metrology Processes & Methods: Develop, write, and validate CMM programs and define measurement methods (GD&T) for new product introduction and production.
- Quality & Data Analysis: Analyze measurement data to drive continuous improvement, investigate discrepancies, perform uncertainty analysis, and resolve root causes of inspection issues.
- Strategic & Operational Management: Manage gage inventories, schedule calibrations, oversee subcontractors, and manage capital equipment forecasting for new technology.
- Cross-functional Collaboration: Partner with engineering, manufacturing, and quality teams to ensure product quality and resolve technical challenges.Supervised the Metrology Team responsible for calibrations of instruments and equipment site wide.
- Supported and collaborated with manufacturing, quality control, and process engineering departments to ensure compliance.
LABORATORY OPERATIONS SPECIALIST I – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
Foster City, CA
08.2020 - 12.2021
- Managed laboratory operations projects, including new instrument and software implementation, by working closely with Analytical Operations (AO) personnel to determine laboratory needs and user requirements.
- Coordinated demonstration and selection of new laboratory systems, collaborating with various teams to ensure project goals met timelines and budget constraints.
- Led and assisted with continuous improvement projects to enhance laboratory efficiency and compliance of all AO laboratories.
- Provided support across the entire instrument lifecycle from requirements gathering, selection and purchase, to installation/qualification, operational support, and finally decommissioning and retirement.
- Fostered collaboration among AO, Facilities, QA, and onsite construction teams to prepare site for high-priority projects across AO.
- Led the installation and qualification of numerous GMP/Research instruments and equipment including a fleet of 10 Waters Liquid Chromatographs, Rudolph Polarimeter, Differential Scanning Calorimeter (DSC), Thermogravimetric Analyzer (TGA), and Pion Microdisc Profiler.
- Coordinated and executed relocation efforts for all laboratory instruments moving from B368 to B357.
- Facilitated training sessions with instrument vendors to enhance AO staff's proficiency with new instrumentation.
- Performed installation and activation activities for temperature probes on all temperature-controlled units in B357.
LABORATORY OPERATIONS TECHNICIAN II – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
Foster City, CA
07.2016 - 08.2020
- Ensured inspection readiness by contributing to improvements to regulatory compliance and operational excellence of the GMP labs.
- Managed onsite vendor PMs, calibrations, qualifications, and repairs of GMP instrumentation, ensuring all documentation met regulatory compliance standards.
- Performed preventative maintenance and calibrations on GMP instrumentation including but not limited to HPLCs, UPLCs, Temperature Controlled Laboratory Equipment, Appearance Lightboxes, Water Meters, Sotax Disintegrator, Milli-Q Water Systems, and Tablet Friabilators.
- Supported Analytical Operations laboratories through metrology functions, project execution, and oversight of service vendors to ensure operational efficiency.
- Executed system audit trail reviews per 21 CFR Part 11 requirements on standalone computerized systems such as UV-Vis Spectrophotometer.
- Reviewed instrument logbooks and security audit trails for completeness, adherence to GDP, and regulatory requirements to ensure operations were compliant with Gilead SOPs.
- Provided support in executing department-wide laboratory relocations and various special projects including four major laboratory building moves and the segregation of GMP and Research laboratories in AO.
LABORATORY TECHNICIAN II – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
Foster City, CA
10.2012 - 07.2016
- Provided support to Analytical Operations through various functions in the Laboratory Operations, GMP Warehouse, and Quality Control groups.
- Provided support for daily operations, special projects, and inspection/remediation activities.
- Completed all job responsibilities while adhering to company and regulatory requirements.
- Supported Analytical Operations laboratories and staff by ensuring the labs and instrument were maintained in a state of regulatory compliance; special attention given to standalone computerized systems and 21 CFR Part 11 and Annex 11 requirements.
- Provided support in planning and executing department-wide laboratory relocations and various special projects.
- Facilitated capital instrument purchases by collaborating with teams to identify needs and ensure timely acquisition.
- Oversaw laboratory instrument service contracts and vendor management to ensure compliance with service standards and operational readiness.
- Reviewed instrument logbooks and security audit trails for completeness, adherence to GDP, and regulatory requirements to ensure operations were compliant with Gilead SOPs.
- Provided support for Supply Chain operations by ensuring scheduling, purchasing, routing and storage of API and drug products were in a state of compliance adhering to regulatory requirements.
- Prepared work orders, purchase orders and material transfer requests and reviewed them for accuracy and appropriateness.
- Facilitated communication and bridged information gaps among Analytical Operations, Quality Assurance, Formulations, and Facilities to enhance collaboration and operational efficiency.
- Extensive experience with Temptale technology and products with temperature sensitivity.
- Prepared solutions in support of GMP testing by accurately weighing and transferring materials per quantitative method requirements; documented appropriately while adhering to strict GMP and GLP requirements of the QC laboratories.
- Managed laboratory reagent inventory and purchased laboratory reagents and supplies.
- Conducted daily walkthroughs with QC management to assess laboratory compliance and promptly addressed any identified issues.
LABORATORY SERVICES TECHNICIAN – STOCKROOM & GLASS STERILIZATION
VWR Catalyst.
Foster City, CA
03.2012 - 10.2012
- Sterilized laboratory glassware using aseptic techniques, ensuring compliance with GMP guidelines and regulatory standards to maintain laboratory integrity.
- Collaborated with facilities and quality control management to streamline glassware restocking process.
- Coordinated upkeep of building stockrooms and ensured supply inventories were appropriately ordered and replenished.
QUALITY CONTROL
New United Motors Manufacturing Inc.
Fremont, CA
08.1998 - 04.2010
- Ensured adherence to quality and safety standards in vehicle manufacturing and production.
- Monitored and enforced safety protocols during production to maintain a secure work environment.
- Contributed to Kaizen 'Continuous Improvement' initiatives, achieving ergonomic adjustments and job rebalancing.
- Trained in Toyota Production System (TPS) building automobiles safely and efficiently at low cost to customers.
Education
INTRODUCTION TO PROJECT MANAGEMENT -
PROJECT MANAGEMENT INSTITUTE
NEW TOWN SQUARE, PENNSYLVANIA01.2020
ALLIANCE HPLC OPERATION & PERFORMANCE MAINTENANCE CERTIFICATE -
WATERS CORPORATION
PLEASANTON, CALIFORNIA01.2016
Associate of Science - BIOTECHNOLOGY
BIOHEALTH COLLEGE
San Jose, CASkills
- Instrument Metrology
- GxP and Regulatory Standards
- Data integrity audit
- CFR compliance
- Data and Specification Review
- Preventive Maintenance and Calibration
- System Audit Trail Review (SATR)
- Logbook Review
- Data Review
- Vendor management
- Waters HPLC systems
- Waters Acquity and H-Class UPLC
- Mettler-Toledo titration
- Mettler-Toledo SevenExcellence pH Meter
- Mettler balances
- TGA/DSC
- PXRD
- Gilson Liquid Handler
- Environmental Chambers
- Temperature Controlled Equipment
- Temperature Monitoring Systems
- Milli-Q Water Systems
- Manufacturing practices
- Laboratory practices
- Documentation practices
- Media Preparation
- Microsoft Project
- Trackwise (GTrack)
- VeevaVault (GVault)
- Documentum (GDocs)
- Empower
- MAXIMO management system
- ComplianceWire (GxPLearn)
Timeline
METROLOGY LEAD
Lonza Biologics, Inc
03.2022 - 02.2025
LABORATORY OPERATIONS SPECIALIST I – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
08.2020 - 12.2021
LABORATORY OPERATIONS TECHNICIAN II – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
07.2016 - 08.2020
LABORATORY TECHNICIAN II – ANALYTICAL OPERATIONS
Gilead Sciences, Inc.
10.2012 - 07.2016
LABORATORY SERVICES TECHNICIAN – STOCKROOM & GLASS STERILIZATION
VWR Catalyst.
03.2012 - 10.2012
QUALITY CONTROL
New United Motors Manufacturing Inc.
08.1998 - 04.2010
Associate of Science - BIOTECHNOLOGY
BIOHEALTH COLLEGE
INTRODUCTION TO PROJECT MANAGEMENT -
PROJECT MANAGEMENT INSTITUTE
ALLIANCE HPLC OPERATION & PERFORMANCE MAINTENANCE CERTIFICATE -
WATERS CORPORATION