James Reed

· Lead to completion of project milestones and organized own work to meet project task deadlines

· Promoted Current Good Manufacturing practices compliance within the workplace by following site cGMP procedures and incorporated cGMP regulatory and safety compliance into all assigned projects scope and design.

· Collaborated with Process Development groups during the development of new products to provide a commercial operations perspective.

· Used operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.

· Monitored the technical documentation for the production and processes approval.

· Ensured all production equipment and systems were following Current GMP.

· Managed completion of relevant process activities by following established Standard Operating Procedures.

Modeled and analyzed the economic value and environmental impact of process synthetic processes and manufacturing concepts.

Evaluated novel chemical processes for the identification of process improvement opportunities and requirements vital to ensure safe and successful scale-up and tech transfer.

· Perform process monitoring and data analysis and data preparation for presentation in several forums including project team meetings.

· Develop and sustain a culture of quality, safety, and continuous improvement within the team for effectiveness and efficiency of resource utilization.

· Effectively maintained good communication and collaborated with cross functional colleagues and external partners for successful completion of projects.

· Participated in the tech transfer and scale-up of developed processes to pilot GMP manufacturing.

· Worked on problems of diverse scope (bridging upstream and downstream processes).

Supported capital projects,validation and commissioning involving following IQ/OQ/PQ protocols, functionality testing and interface testing during the operational qualification.

Authored / revised SOP's batch records, deviations, investigations and training materials to support continuous improvements of manufacturing processes.

Worked closely with MSAT, Regulatory, Quality Control and Quality Assurance groups as needed to ensure compliance with GMP regulations and data integrity.

· Helped lead all planning, scheduling and production functions to ensure adequate materials, equipment and personnel were available to meet the development schedule.

Trained Managers, Supervisors and manufacturing personnel on all processing equipment and championed the EHS to improve safety throughout the site.

Selected Accomplishments

· Awarded for executing a highly visible developmental product in a timely manner with minimal capital investment for a new customer generating more than $10 million in revenue.

· Used Root Cause analysis to Re-Engineer the removal of process waste from the Centrifuge to improve employee ergonomics and location of disposal. Adding a yearly cost savings of $30,000.

· Trained and managed new and existing employees to increase productivity efficiently and safely. Resulted in increasing OEE 95-98% with no Non-Conforming Issues.

· Analyzed and troubleshot equipment and process defects; presented findings and proposed recommendations to management with a cost savings of $200,000.

· Designed and implemented changes to the work processes that had a 30% increase in efficiency and productivity.

· Facilitated Kaizen teams that increased efficiencies of product lines by 50-100%.

· Utilized DFMEA/PFMEA to eliminate process and equipment failures, resulted improving CPK-1.33

Experience

· Primary liaison for R&D on project developments, requiring oversight and collaboration on product scale ups, evaluating results ensuring process efficiency and quality standards.

· Experience with and knowledge of batch and continuous chemical reactor and liquid particle dispersion process technology and development.

· Managed product campaigns manually and through automation to completion.

· Used Batch Records to be in compliance for product campaigns and GMP.

· Made process and raw material adjustments to meet customer specifications.

· Executed routine manufacturing activities including purification/solution formulation and equipment preparation (set-up, CIP and SIP)

· Re-engineered applications to implement process improvements.

· Provided engineering support of automated manufacturing production equipment for both upstream and downstream processes.

· Identified bottlenecks and process challenges; with recommended strategy solutions.

· Consistently met project schedules, workload goals by managing and allocating proper staff levels.

· Delta V ability; to use process historian and analyze data in trouble shooting, process monitoring, parameters and data trend analysis.

· SPC ability; to analyze in-process data to evaluate trends of critical process parameters.

· Demonstrated good judgement in selecting methods and techniques for obtaining solutions.

· Improved product quality by identifying manufacturing issues developing advanced manufacturing cost-effective solutions and overseeing successful implementation into production.

· Applied Elemental Analysis to test in process products to confirm the control limits specification.

· Used AEMS quality control tool to monitor, improve response flow checklists to remedy production processes when they deviated outside the control limits.

· Manually intervene the Delta V software to trouble shoot processing units with the use of Allen Bradley PLC software.

· Executed Root Cause Analysis to improve the value stream mapping of the process to drive continual improvement of key operational measures.

· Utilized 5S to create a standardized environment improving productivity, safety, and cleanliness.

• Serves as an engaging and collaborative teacher/trainer providing internal standardized lean training and consulting support for Lean & Six Sigma tools, data mining and presentation with heavy emphasis on MS Excel.

· Communicated Process Performance across shifts and departments.

· Wrote technical documentation for unit operation. (SOP)

· Knowledge and experience of process safety tools/processes (hazard assessment, MOC, PSSR, etc.) and capable to ensure safe operation.

· Created MOC’s (Management of Change) and DCR’s (Document Change Request) to improve process and safety measures.

· Engage with Environment, Health and Safety initiatives and ensured all requirements and policies are observed during change implementation.

· Complied with the Company Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations.

· Supported maintenance and preventative maintenance on critical equipment.

· Utilized JD Edwards ERP to manage daily tasks within the facility.

· Provided support on capital projects, validation and commissioning involving following IQ/OQ/PQ protocols, functionality testing and interface testing during the operational qualification.