Leatha Brown Email & Phone Number

Patterson, CA, US

Rocklin, California, United States

Hayward, California

• Manages site investigations to ensure that all nonconforming products/processes are adequately controlled, dispositioned. Leads investigations for high visibility issues and trends for site leadership.
• Manages site corrective and preventive actions to prevent non-conformance from occurring or reoccurring. Develops and manages plans for implementation to ensure actions are effectively implemented and ensure closure of.
• Reviews and approves documentation and changes for commercial site teams (Ops, Tech Services, Validation, and QC). Ensures compliance with Regulatory requirements for site documentation.
• Manages TrackWise Change Control, Deviation/CAPA, and Protocol modules.
• Reviews revision of GMP-related policies, SOPs, test methods to ensure the corporate procedures are up to date with regulations.
• Supports internal quality audit and FDA inspections as subject matter expert and Quality representative to ensure successful completion of audits with no observations. Prepares audit response documentation.

Fremont, California

• Developed pilot and commercial scale distillation piping and instrumentation diagrams (P&ID) and process flow diagrams (PFD) using AutoCAD for batch chemical purification for air and moisture sensitive liquid.
• Design of $1.2M distillation system for high volume purification (25 MT per year capacity) of air/moisture sensitive chemical precursor. Participation in custom installation and facility modification to accommodate new.
• Sourced and constructed chemical purification and collection manifolds, managed equipment vendor and contractors, material selection, budget management, manual piping construction and purchase up to $100,000 per.
• Managed cost estimates for equipment construction, modification and process improvements for multiple project timelines. Compiled bill of materials (BOM), spare parts and equipment for process development and.
• Design, installation and maintenance of new facility hazardous material (Fluoride, HF) removal skid, capable of automated, continuous operation with a capacity of up to 100 gallons of waste water per day.
• Developed SOP, process parameters and revisions for manufacturing processes of multiple air/moisture sensitive chemistry process trains. Conducted process improvement for savings of $1M for ongoing process.

Hayward, California

• Lead engineer in process validation and qualification of new and reformulated products, including GMP document preparation, design of experiment (DoE) at R&D scale, scale up, oversight and execution of all commercial.
• Prepared and revised cGMP compliant documentation including demo and commercial Manufacturing Batch Record (MBR), process validation/qualification protocol and summary report including statistical analysis, equipment.
• Performed production personnel training for new processes and process changes/improvements and product specific manufacturing requirements beyond standard requirements typically performed.
• Review and approval of manufacturing drawings for commercial and pilot scale tooling, vendor communication management for tooling and equipment optimization.
• Performed and oversaw tech transfer activities for contract manufacturing and packaging organizations in US and Taiwan.
• Performed troubleshooting of equipment and manufacturing issues in order to increase efficiency and provide commercial manufacturing support. Created engineering drawings for arresting baffles for solid dosage product.

Berkeley, CA

• Measured and analyzed rates of enzyme consumption of immobilized proteins in the presence of surfactant.
• Studied effects of protein film aging on proteolysis rates.
• Compiled and organized rate data for further analysis to be incorporated into publication.

Grass Valley, CA

• Managed three person liquid and solid chemical laboratory waste processing team.
• Created and implemented chemical inventory management system (Microsoft Word and Excel) for the maintenance of chemical and biological laboratory supplies.
• Prepared chemical experiments and samples for faculty members.

Ames, IA

• Participated in developmental research using VASP and GAMESS software to locate minimum energy silicon oxide clusters.
• Planned and managed weekly multimedia presentations to Department of Energy faculty on research findings.
• Created poster and proposed further research for participation in National Science Foundation/Department of Energy poster session.