Leslie Mathie

· Develop regulatory plans to support medical device products from development to market via product life-cycle management.

· Prepared documents for regulatory submissions and registrations, including but not limited to FDA, EU, and other foreign regulatory bodies, including:

§ 510(K)

§ 510(K) specials

§ De-Novo

§ EUA

§ Q-Sub

§ EU-MDR

· Support/develop compliance activities to support Quality Management System compliance with international and domestic policies and regulations

§ 21 CFR 820

§ GMP

§ ISO 13485

§ ISO 14971

§ EU MDR Technical files

• Review modifications to existing SOPs, test methods, process changes, design changes
• Support Design and Development to 21 CFR 820 including:
• Design and development plans
• Design Review meetings
• Functional input/output development
• Design verification and validation (including software V&V)
• Design Transfer
• Development and support for performance testing, including
• IEC 60601 family
• ISO 10993- Biocompatibility
• Develop risk management process to ISO 14971, including:
• FMEA including SaMD
• Risk management workshop
• Risk management plans
• Supplier and contract manufacturing support
• Support compliance to IEC 60601 family
• Support regulatory audits and response to 483’s
• Provide Project Management Support for medical device development through final device marketing
• Waterfall/Agile/Hybrid
• Project execution plans
• Schedule
• WBS
• Burn rate management

.

• Improved product quality by implementing and monitoring rigorous quality control processes
• Assisted management in establishing long-term strategic goals related to overall product quality and customer satisfaction levels
• Enhanced customer satisfaction through timely resolution of complaints and implementation of corrective actions
• Optimized supplier relationships by closely monitoring their performance, providing feedback, and addressing any quality concerns promptly
• Increased production efficiency by identifying bottlenecks in the manufacturing process and recommending improvements
• Conducted risk assessments to minimize potential quality issues, ensuring product safety and compliance with industry regulations

• Design in-line analytical solutions for GMP manufacturing of cell culture products
• Develop method validation protocols for analyzer and manufacturing equipment for GMP release
• IQ/OQ/PQ development for automated analytical solutions
• Machine learning/AI model development- PLS/Neural Net
• Develop method validation and transfer protocols for GMP release including 21 CFR 11/ Information Security implications
• Tech transfer support with analytical equipment launch Machine learning/AI model development for Raman analyzer- SynTQ
• Project (PM)/Technical Manager (TM) for GMP tech transfer analyzer projects
• Projects:
• PM/TM CCMAS- Cell Culture Monitoring Analytics Standardization
• PM/TM· Raman- CHO based commercial molecule analysis
• TM- CB4T- Titer implementation with Cedex Bio analyzer for CHO based commercial molecule -PM/TM
• Mentored junior engineers, providing guidance in best practices and fostering professional growth opportunities

Project Manager- Technology - Analytical Equipment Replacement Project

At Texas City Chemicals I worked project to replace aging equipment – Small Capital Project (1MM)

• Worked with core team and EPC (contractor) to define value proposition and scope
• Conducted technology research on best available equipment
• Manage EPC contractor to develop WBS, estimate and BOD
• Review / Approve P&ID’s, PFD
• Manage project team to ensure all deliverables on time and budget

Project Manager AI- Machine Learning – Work Scope 2 - Small Capital Project (75K)

At Naperville Site

• Worked with core global team to define scope
• Conducted technology research on best available AI- Machine learning software
• Developed criteria and scoring
• Developed WBS and estimate
• Manage project team to ensure all deliverables on time and budget
• Participated in relevant industry conferences keeping up-to-date with the latest trends in analytics engineering practice

Assurance, Interface and Risk Advisor (AIR) -San Joaquin Valley Business Unit, Major Capital Projects -Bakersfield, CA

Risk Adviser

• Developed, executed and managed a comprehensive risk management process to proactively identify and mitigate project risk across all projects and functional teams (Facilities Engineering, Subsurface Engineering, Decision Analysis, Land, Business and Commercial, Construction, HES, Policy, Government and Public Affairs, and Operations)
  

Project Assurance /Quality Management

Develop, execute, and manage all project assurances

• Managed and executed the individual assurance engagement plans and workshops totaling over 100 individual assurances
  
• Lead and executed the development and implementation of the project execution plan
  
• Developed and lead project management of change (MOC) process
  

Project Engineer- Analyzers– (Lost Hills Diatomite Growth Project)

Designed in-line analyzer system for detection of hydrocarbon and sulfur speciation to support oil recovery on small scale pilot- Yokogawa GC8000/ThermoFisher Sola II with analyzer structure and sample conditioning system

Collaborated with systems integrator and internal stakeholder groups (SCADA, facilities engineering) to design and execute optimum analytical system with zero escape gases

Reviewed and authorized P&ID's

Lubricants Product Technical Specialist

• Data mine large information sheets to develop recommended profiles for product offerings
• Collaborate with manufacturing, product development, legal and marketing to recommend technical solutions to customer needs and product launch
• Recommend analytical analysis to complex finished lubricants product investigations by interpreting test data

Quality Assurance Chemist-Richmond Refinery -Richmond, CA

• Technically assessed, developed methods and implemented different technology options for the laboratory and refinery
  
• Designed, Installed, calibrated, validated and maintained several analyzers for detection of various hydrocarbon and element components including : Refinery Gas Analyzer multi-loop GC- Agilent 7890A with Chemstation, Simulated distillation GC-Agilent 6890N with Chemstation , Aromatic detection by SFC 400 with EZCHROM Elite
• Integration of GC, HPLC, and Raman data into LIMS system
• Developed and implemented maintenance schedule for all instrumentation in the laboratory and field using in -house instrument technicians and 3rd party vendors managed by developed in-house database
  
• Improved quality management systems for refinery laboratory - Product Quality from 83% to 99% measured against the Product Quality Testing Audit based on ASTM D6792
• Developed and managed statistical process control in part by utilizing statistical control charts and total quality management
• Managed ISO 9001-2008 lubricants compliance
  
• Headed introduction of RAMAN technology into the laboratory and refinery increasing productivity by 25% including development and maintenance of chemometric models by Thermo Scientific™ GRAMS/AI™ Spectroscopy Software
• Project manager for in-line analyzer projects with integration into DCS system ( Honeywell, Yokogawa) - B&S RAMAN Component Tank Project, SDA Cutter Optimization System Project(in-line viscometer project), Commissioning and Closure of D&R RAMAN Analyzer Project
• Coordinated installation and mechanical work using in-house trades and contract vendors
  

• Collaborated with scientists and industrial hygienists to identify various chemicals for control and protection of LLNL employees
• Developed instrument methods, calibration standards, and validation for GC/MS Agilent 5977 for several research samples
• Waters 1500 HPLC Project- investigated proper instrumentation for HPLC with UV-vis detector for use in research projects
• Maintained NPDES Stormwater testing program for LLNL