Jeffrey Wells Email & Phone Number

Los Angeles, Ca, Us

Los Angeles, Ca, Us

Minneapolis, Mn, Us

Westlake Village, California, Us

-Led new product development using agile methodology to translate user needs into functional prototypes with real-time physician review of samples-Responsible for verification and validation activities-Oversaw process development and validation for new products-Managed team of engineers to support multiple programs including DFM cost down efforts, early stage R&D for new product sku’s, cleanroom setup and line validations, and engineering support of current product portfolio

Westlake Village, California, Us

-Responsible for planning and manufacturing of portfolio of products (20M)-Oversaw cleanroom operations, drove line optimization and sustaining projects-Drove cost savings projects including raw material, component, and process yield-Managed new product introduction, line setup, process validation, and scale up for multiple products-Launched 2 new products-Led sustaining programs including product improvements and updates based on customer feedback-Managed demand and manufacturing slowdown during COVID and ramp up of manufacturing to maintain inventory

Westlake Village, California, Us

-Drove process improvement and manufacturing capacity projects-Identified and led cost down initiatives-Product design and validation to address customer feedback-Process development using DOE, tool design, and validation to support new product introduction (NPI)-Test method development and validation

Abbott Park, Illinois, Us

• Developed and validated test methods for inspection and measurements to support production and design verification activities• Drove process improvement efforts to increase operational efficiency• Developed automation solutions for new and existing processes• Authored equipment specifications, IQ/OQ/PQ procedures and drove validation efforts for production processes

San Diego, Ca - California, Us

San Diego, Ca - California, Us

• Coordinated aseptic manufacturing of cardiac-derived cell therapies in ISO 7 and ISO 5 classified clean rooms according to FDA compliant Good Manufacturing Practices and facility operations• Oversaw the manufacturing scale-up of pre-market drug products for clinical trials. Drove optimization of facility and processes resulting in increased production capacity• Supply chain management: streamlined procurement, logistics, material management, and production support procedures• Designed and automated manufacturing workflow and inventory management systems• Troubleshooting to ensure environmental controls in the processing suite• Testing and validation of software tools for clinical subject treatment assignment and data cleansing• Authored and updated annual Investigational New Drug amendments and reports for FDA• Implemented and continually improved quality systems and processes to meet regulatory requirements• Trained and managed team of engineers and scientists

San Diego, Ca - California, Us

• Directed product stability program to define and extend the shelf life of cardiac cell therapy clinical products• Coordinated process development studies and authored Chemistry Manufacturing and Control reports for FDA filings• Managed applications and agency relations for California Tissue Bank and state of California drug manufacturing licenses• Responsible for production of clinical products in cleanroom facility under cGMPs• Analyzed process data to identify trends and implement statistical process controls• Implemented aseptic processing validation and environmental monitoring programs

Irvine, Ca, Us

• Designed and manufactured a simulation tool for proof of concept testing of a heart valve replacement product• Upon success of first phase and revision of project scope, enhanced the tool for use by product marketing• Adapted the simulation tool and created a training model for surgeons in the field • Established design qualifications and test methods for compliance with project requirements

Thousand Oaks, Ca, Us

• As part of the reporting and analysis team for clinical trials, developed and validated clinical data reports to support FDA submissions• Wrote and executed test cases to validate and support the implementation of an updated batch upload program• Developed training materials for the new electronic data capture software• Programmed macros to facilitate increased efficiency in data cleansing and analysis for data lock and analysis• Ensured compliance with change management processes

Nowhere City, Nv, Us

• Participated in building core database and data verification for web-based Business Intelligence company• Completed quality control checks including use cases and web site functionality

Master Of Science (Ms), Biomedical Engineering

Bachelor Of Science (Bs), Biomedical Engineering