◦ Redesign of the site’s risk assessment program to meet regulatory requirements and company growth. ◦ Regulatory compliance gap assessment and correction of the site’s defect trending program. ◦ Facilitation of the site’s Inspection trending program to ensure regulatory compliance and continuous improvement. ◦ Management of the site’s continuous process verification program to ensure process control.

• Led a team of process knowledge owners that provided floor support to the site’s Inspection and Packaging operations. • Oversaw Client support and escorting. • Developed and oversaw a program to remediate issues on the manufacturing floor as quickly as possible while ensuring the remained in a controlled and validated state. • Developed tools for the tracking and communication of 24/7 support activities. • Recognized for Inspirational Leadership by my team.

• As a subject matter expert for Inspection and Packaging operations, led tours of Drug Product Secondary and provided information during audits by regulatory bodies and clients. • Generated, reviewed and approved departmental documentation including standard operating procedures (SOP), forms, trainings, and performance-based assessments (PBA). • Authored numerous deviation investigations and Quality Compliance Assessments, ranging from Minor to Critical SISPQ impact. • Led internal and client-focused projects to address deviations, preventative and/ or corrective actions, and process improvements. • Trained new hires in process improvement methodology and technical / deviation writing. • Project examples: ◦ Creation of a statistically based method for responding to defect limit excursions. ◦ Revision of inspection training to reduce false rejects and increase yield.

• Various size projects (single-week Kaizens to multi-month initiatives) to reduce downtime and increase productivity. Cumulative benefit of $1.5M. • Example projects: ◦ Implementation of count templates to prevent miscounts. Savings of up to $600k/year ◦ Increased semi-automated vial inspection output. Revenue increase of up to $500k/year.

● Independently developed value-based, client-oriented process improvement plans.● Provided guidance on using financial indicators for process improvement.● Performed Lean/ Six Sigma Black Belt projects resulting in increased productivity and reduced capital costs.● Effectively communicated statistical analysis results and recommended changes with management.

Project Management: 3 research projects focused on improving biochemical production capability.● Investigated the use of elevated pressures on the production capability of hydrogen-oxidizing bacteria. • Designed and fabricated pressurized bioreactors. • Collaboratively developed equipment for in-situ monitoring of culture activity . • Led and trained a team of 5 undergraduate and graduate researchers. • Presented findings at the World Summit of Biotechnology, Nov 2016. •Performed root cause analysis, as well as, failure mode and effect analysis to ensure safe operating conditions. • Instrumentation proficiency: Gas chromatography● Developed a genome shuffling protocol for hydrogen-oxidizing bacteria. • Enabled the measurement of key metrics through creation of genetically modified strains. • Validated results through flow cytometry and microscopy.● Investigated the use of a novel catalyst to increase hemicellulose-to-fuel conversion. • Improved hemicellulose degradation through recombinant expression of a novel xylanase. • Collaboratively developed a co-culture to simultaneously dergrade xylanase and convert the sugars to isobutanol, enabling "one-pot" production. • Instrumentation: HPLCSafety Officer • Championed safety in the laboratory. • Provided safety training to new lab members. • Maintained records in accordance with regulations. • Conducted inspections to ensure best practices were followed.Graduate Student Instructor • Senior Chemical Engineering Lab which mimicks a R&D group's investigation of a process for biodiesel production to determine potential for scale-up and economic viability. • Developed manuals for subsequent graduate instructors to streamline the learning process. • Instructed students in the theory and operation of pilot scale equipment, such as a liquid-liquid contactor, batch reactor, and distillation. • Provided instruction in Aspen modeling, economic analysis and report writing.

Undergraduate Researcher● Production of zinc oxide nanowire arrays for acetone vapor sensing. • Analyzed the effects of varying synthesis conditions on nanowire structure and identified optimal conditions. • Instrumentation: Scanning Electron Microscopy.● Analysis of ceria/ zirconia composites for low hydrogen peroxide concentration detection. • Improved the fabrication process resulting in increased electrode stability. • Instrumentation: cyclic voltammetry.Supplemental Instructor- Numerical Methods • Developed hand-outs and lesson plans, improving student understanding and capability.

Administrative Clerk • Created SOPs for document processing, reducing processing time and occurrence of inaccuracies. • Created Access databases resulting in improved tracking of staffing placements and needs.Marine Security Guard • Developed emergency response plans to accommodate changing threats. • Created manuals for incoming NCO's, streamlining the on-boarding process.