Tech Transfer, new product introduction and support of existing product filings.

Installation, commissioning, validation, troubleshooting, process improvement and streamlining of commercial scale MDI filling equipment.

• Quality Assurance review of maintenance work orders. Performed quality assessments of submitted work orders to review for potential product impact due to DCE, part substitutions, equipment troubleshooting, down time, etc.• Performed monthly quality review of equipment logbooks for Factory Operations, Central Utilities Building, IT, Automation and Quality Control. Initiated DRs as required to maintain quality compliance. • Designed and developed conditionally responsive batch record correction tracking templates for use by production supervisors to facilitate coordination between manufacturing associates for error correction tracking in accordance with company SOPs.

• Validation of manufacturing systems used in BacT/ALERT production at bioMerieux including: Capmatic Crimpsealer, Fowler Crimpsealer, Lighthouse Spectrometer, Crimp Inspection systems, Plant Chilled Water utility.• Generation of validation support documents such as User Requirement Specifications, Detailed Design Specifications, Trace Matrices, System Impact Assessments, Component Criticality Assessments.• Generation of Installation Qualification & Operational Qualification protocols and execution on manufacturing systems.• Walk down and red line of process P&ID’s. • FMEA assessments and risk mitigation.

• Creation of installation, commissioning, operation and maintenance manuals on new equipment.• Technical review of P&ID for pressures, flow rates, equipment sizing, stream compatibility, etc.• Coordinating with project managers, vendors, subcontractors, engineering departments, and fabrication sites in support of document creation.

Responsible for oversight of the production of $6M of process analyzers for the petrochemical industry.• Trained and supervised employees on day to day manufacturing operations.• Managed design, procurement, fabrication, assembly, testing and shipping.• Promoted sales while entertaining international clients.• Supervised FATs on completed systems.• Engineering analysis of manufacturing, P&ID and electrical diagramsTech transfer and startup of two new manufacturing facilities.• Designed plant layout and material flow.• Supervised subcontractors for the installation of utilities, IT network, inventory control systems, tooling, assembly stations, R&D and offices areas. • Screened qualified candidates, interviewed and hired new employees.• Ongoing optimization of processes with a focus on lean manufacturing.

Project management and formulation development for cGLP projects.• Coordinated with sponsors regarding project expectations, timelines and criteria for success.• Supervised formulation development and testing of topical wound care formulations.• Manufactured aseptic GLP batches for use in clinical trials.• Managed personnel, resources and timelines for stability testing time points.• Analyzed data and prepared formal summary reports.• On-site clinical facility visits in support of ongoing efficacy studies.• Dozens of SOPs, batch records, study protocols, test methods, and project reports authored.Optimized of pilot scale manufacturing operations for consistent quality and repeatability.• Hundreds of novel formulations manufactured and tested; Inhalational (MDIs, DPIs, Nebulizers), Oral (tablets, capsules), Topical (gels, pastes, creams, foams) and Parenterals.• Performed root cause analysis on process inconsistencies and implemented appropriate solutions.• Designed and installed multiple safety control systems on manufacturing equipment.• Designed, fabricated, assembled and tested a novel pneumatic nasal testing apparatus.• Installed and tested environmental control systems.

Produced natural topical products in a FDA regulated facility using batch reaction vessels• Up to 1500kg of product produced per day with 98% overall batch approval• Manufactured lotions, creams, ointments, waxes, balms, salves, powders and infusionsDesigned and presented process improvement recommendations to upper management• Oil filtration system significantly improving batch yield and processing times• Recycle stream heat exchangers for decreased heating and cooling times• Volumetric flow and level controllers for automated liquid addition to batch vessels • Liquid storage of raw materials for improved energy savings and reduced batch times• Intermediate product storage for streamlined material flow from production to filling

Supervised 6 employees in daily retail duties. • Managed all projects at my location to ensure accuracy and on-time completion. • Interacted with vendors on custom production orders.