Responsible for the daily operations of the genotyping and regenerative medicine laboratory. Lead a team of eight laboratory technicians and two cell scientists performing DNA extractions, SNP genotyping, real time quantitative PCR and research on creating induced pluripotent stem cells from peripheral blood mononuclear cells. Work collaboratively with the CLIA Laboratory Director on strategic and operational initiatives. Ensure training, staff competency, SOPs, and software is up to date and in adherence to Federal, State and accreditation standards. Investigate and troubleshoot out of control testing results, instrument errors and reagent issues. Manage the laboratory budget, vendor contracts, and equipment ordering/maintenance while constantly looking for ways to improve quality and efficiency of the laboratory

Responsible for the overall operation and testing performed in the Quality Control Laboratory and the manufacturing of apheresis platelets. Manage and monitor the activities of two supervisors and nineteen staff members performing apheresis platelet manufacturing and a variety of testing on platelet pheresis, whole blood and red blood cell products. Ensure all procedures are followed and that the laboratory is in compliance with all CLIA, AABB, FDA-CFR and Massachusetts state regulations. Responsible for organizing and overseeing proficiency surveys, tracking and trending QC data and reviewing this QC data and any issues with the Medical Director

Supervision of nine employees that work in conjunction with a manufacturing team to manufacture platelet products in addition to performing a variety of testing that include, bacterial detection testing (Biomerieux BacT ALERT 3D), automated hematology testing (SYSMEX XE-2100D), manual leukoreduction testing (Nageotte chambers) and pH testing (Thermo Scientific Orion Star), while fulfilling the requirements of Finished Product Quality Control Testing as required by the FDA. Other duties include managing the laboratory budget, reviewing weekly timecards, assisting in equipment validations, implementing /revising procedures, and ensuring staff are properly trained and assessed for competency

Responsible for all aspects of the RIA / EIA Laboratory including the supervision of a nine Laboratory Technologist team performing large volume, high complexity testing in the areas of Immunology (RIA / ELISA), Chemistry and infectious diseases. Utilize Six Sigma to establish and maintain quality control and quality assurance programs, within the laboratory. Ensure compliance with standard operating procedures, departmental policies, federal, state and local regulations. Ensure the laboratory follows all CLIA, CAP, HIPAA and OSHA guidelines. Ensure training and periodic competency assessments are performed by all technical staff. Responsible for the corrective actions and documentation of all deviations from the laboratories preanalytical and/or post analytical processes. Maintain inventory of supplies, equipment and reagents. Radiation Safety Officer: responsible for training, ordering, handling and disposal of all radioactive material used for testing. Testing and troubleshooting on a wide variety of laboratory instrumentation. Scheduling, time-card approvals, hiring, and discipline.

Testing of biological samples for therapeutic and illicit drugs utilizing a wide variety of analytical techniques including GC/MS and HPLC. In addition, testing of various metabolic indicators, heavy metals and toxins by AA. Responsibilities included editing and writing standard operating procedures, instrument validations, QC monitoring, and supervising all training and competency assessments.

Responsible for the daily operation and testing activity for automated and manual serology and viral immunology test procedures. Provide supervision, guidance and leadership within all areas of the laboratory including orientation, training, performance evaluations and discipline, while promoting an environment of learning and professional development. Supervision of up to 15 Laboratory Technicians testing approximately 3000 blood samples daily. Ensure testing is performed accurately and efficiently adhering to CGMP standards, AABB guidelines, and FDA regulations. Perform annual competency assessments and work performance reviews. Daily review of testing and equipment maintenance records. Perform equipment and procedural validations. Review, update, and implement laboratory procedures. Maintain inventory of reagents, equipment and supplies. Scheduling and weekly timecard approvals. Testing and troubleshooting on the following instrumentation: Olympus PK7200 (ABO/Rh, CMV, and Syphilis); Hitachi 717(ALT); Abbott Commander System (HIV1/2 and HBsAg); and the Ortho Summit Processor (HCV, HBc, HTLV, and Antibody Screening). Additional Leadership skill training: GMP Orientation and GMP Fundamentals for Supervisors, STAT-A-MATRIX Problem Solving Basics, Achieve Global Leadership for Results, Personal Practices for Supervisors (Legal, interviewing, positive discipline), and Quality/GMP Engineering.