Melissa Owen Email and Phone Number

Scientist primarily responsible for process improvement projects, troubleshooting and investigations.• Currently leading a 15 member project team responsible for the development of new data transfer software that is Windows7 compatible. o Direct team members’ activities to ensure adherence to project schedule.o Communicate project status to upper management and stakeholders.o Managed resources through increasing scope and complexity.• Managed a process improvement and software development project which resulted in $50K/month savings for department. o Assembled a 10 member, cross-functional unit team. Coordinated team members’ activities to allow for an on-time launch of the software and process updates.• Leader of Readiness Team assembled to ensure the Quality Labs are prepared and appropriately trained on new test methods. o Communicate project status and needs with project lead and QC leadership.o Manage the schedules of five dedicated resources and ensure project deliverables are provided on time.

Project leader for transfer and validation of a Drugs of Abuse Testing reagent. Provided technical support of Clinical Chemistry products.• Multi-functional unit team that established the project schedule, wrote the risk assessment, and created manufacturing procedures and specifications. • Developed goals and timelines of the reagent validations with Research & Development. • Prepared all validation documentation. Collaborated with members of Manufacturing and Quality to ensure work was performed in accordance with the project schedule. • Organized and performed characterization studies for the validation of reagents. Wrote protocol, performed testing and wrote a technical summary of the studies.• Conducted investigations into failures of clinical chemistry products and recommended disposition of product. • Coordinated and performed analyzer training for departmental workers.

Responsible for the investigation of customer complaints and inquiries. Performed root cause investigations and worked with affiliates to provide recommendations to customers. Organized and performed customer satisfaction studies. Involved in latex washing characterization studies.• Managed outside vendors to improve reagent that did not meet product claims. Met with vendor on a monthly basis and worked with scientists in order to test modified material. Resulted in improved reagent performance.• Organized extensive customer requested study in collaboration with account manager. Obtained reagents and ensured testing of 1500+ patient samples was performed on multiple analyzers. Interacted with customer during product testing.• Led sample stability study requested by key customer. Organized blood draws, prepared samples and tested over a 35 day period. Results helped customer establish storage and stability of Clinical Chemistry and Therapeutic Drug Monitoring patient samples.