David J. Sánchez Email and Phone Number

Service provider for Pharmaceutical and Medical Device Industry.

1. Implementation of projects for the tableting setup to reduce lead time and increase yield.2. Subject matter expertise and process engineering supporting in-line products, leading problem solving,process improvement and product/process/equipment qualification.3. Optimizing deviation management based on risk assessment outcome per International Conference onHarmonization (ICH) Q10 and ISO 9000:2015.4. Optimized tableting set up to achieve target weight and hardness by using statistical process control(SPC) and process performance data for establishing reject main-compression force without exposingthe tooling to excesive overloads and saving material from discards.5. Optimizing with design of experiment the recovery active ingredient in the tablet-dissolution testingusing autosampler in vessel-batch system.6. Data managent and scrutiny for performing proactive processs analysis and continued processverification.

Process engineering supporting the commercialization of Insulin Device System (medical device).Optimized cleaning process reducing cleaning times from 10 hours per week to 2 hours per week.2. Process engineering supporting the manufacture of One Touch Ultra Strips in enzyme formulation, web printing, padding, lamination and finished slit & vial. Non-conformance investigations. Assessment of CalCode calibration to control bias and keep formulation in target performance ensuring target success rate.3. Non-conformance investigations and root cause determination on electrochemical cells stripsmanufacturing and in the assembly of insulin device system

1. Coaching staff for non-conformance / complaint investigations, corrective actions / preventive actions.2. Technical support (science and statistical) for acrylic sheet casting. acrylic cryo-lathing and chemical vapor deposition for intraocular lens manufacturing.3. Functional test development and method validation.

1. Coaching technical staff on in-line product problem solving, process improvement and product/process and equipment qualification (direct compression, wet granulation, extrusion, wurster coating, tableting, encapsulation functional/non-functional film coating).2. Leading project coordination on commercialization initiatives for scaling up and developing processes for new products, qualifying modified and new equipment such as granulation, single layer / bilayer tableting, drug/fuctional and non-functional film coating.3. Being the liason between manufacturing and technical groups to support in technology transfer, main contact for knowledge transfer and problem solving.4. Leading initiatives for capacity increase such as process optimization, implementing new technology equipment and new or retrofit facilities.5. Supporting prior-approval and routine inspections from different regulatory agencies by proving the technical data / answers to inspector’s or investigator’s requests.6. Providing technical support in the resolution of complex atypical/non-conformance/complaint events that involved application of thermodynamics, momentum, heat and mass transfer such as wurster coating, pan coating, powder blends, tableting / encapsulation machines, lean beef refrigeration and ejectable pastes. Use lean / six sigma for problem solving and improvement. 7. Certified green belt.

Supervising and leading technical team accountable for in-line product support and introduction of new processes, new products and or productivity targets. This included staff supervision & career development, process development, start up and the corresponding the validation activities. This included being the contact team for external manufacturing support. Developed successful personnel toward outstanding site leadership.

1. Project management support for the introduction of new manufacturing facilities and new manufacturing line extensions such as compression facilities, film coating facilities, purified water generation & distribution systems and packaging lines, including all project stages such as the concept definition, system life life cycle, vendor audits, factory acceptance testing, site acceptance testing, until Equipment/Automated Systems Qualifications and Process Performance Qualification.2. Provide technical support for the manufacture and upgrade for the manufacture of solid dosage forms - pharmaceutical processes. This includes being primary contact for issues or questions about the manufacturing process and / or product performance. Assist in troubleshooting complex processing problems through critical and analytical thoughts as well as designing and executing experiments and applying statistical tools for data analysis. Provide scientific & data driven root cause determination for atypical events and justification for planned process, equipment, and software / hardware changes. Evaluating impact of process changes on final product properties.3. Design and development of process validation protocols, the execution and reports for Purified Water Systems, Manufacturing Process, Computer & Automated Processes, Cleaning Processes, and Shipping Studies, in accordance with the current company procedures and cGMP.4. Review and approval of the documentation related to System Life Cycle Methodology delivery documents (Quality Assurance Plan, Configuration Management Plan, Requirements Specifications, Design Specifications, Test Plan, Factory Acceptance Test, Site Acceptance Test) and equipment qualification.

1. Bulk Chemical Plant - The optimization of an Odor Control System. Applied engineering principles in order to optimize the removal of odor exhausted from the different unit operations.2. The installation of a cleaning system in the tanks of the chemical plant. Explored options for equipment and instrumentation to develop a cleaning system that complies with the FDA and GMP regulations and Validation Department.3. Qualification of Tanks Level Indicators and calibration curves.