Lab Management• Scheduling and oversight of day-to-day laboratory activities including protein production and project development work• Planning verification and validation studies for 510(k) and CE submissions based on current guidance• Organizing documentation for 510(k) and CE submissions including all required QCF, PDP, and TFD files• Maintaining up to date design history files for all DiabetOmics assays• Facilitating technology transfer with third party manufacturing sites• Training new employees and junior team members on technical skills and equipment usage• Maintaining and improving the chemical hygiene plan as Safety Officer, including CAPA reports of all incidents

• Developed and optimized lateral flow assays for the detection of autoimmune disorder autoantibodies and biomarkers.• Prepared project timelines and test reports in support of 510(k) submissions.• Authored SOPs and quality control forms to facilitate technology transfer to large scale manufacturing.• Trained team members on the production of lateral flow assay components including gold colloid, gold colloid conjugates, and the spraying of test and control line reagents via liquid handling dispensers.• Maintained project records and design history in compliance with an ISO-13485 quality management

Quality Management• Administered and managed DevLab’s Quality Management System alongside the Lab Director• Ensured compliance with relevant quality requirements including CLIA or CAP• Managed equipment maintenance and calibration calendars as well as daily temperature monitoring• Conducted quarterly quality management reviews to evaluate the laboratories performance and presented results to the management team and staff• Assisted in coordinating Proficiency Testing (PT) activities within the laboratory and ensured that all Proficiency Testing results received are reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action• Performed internal inspection of site quality control processes and internal audits

Assay Development, Validation and Clinical Testing• Validated and implemented testing of three EUA approved SARS-CoV-2 ELISAs in accordance with federal guidelines for verification of performance specifications for high complexity testing• Processed and performed high complexity testing of clinical serum samples for the detection of SARS-CoV-2 antibodies (IgA, IgG, and IgM) by ELISA• Trained in RNA extractions of clinical nasopharyngeal swabs and detection of SARS-CoV-2 by RT-PCR• Performed CAP proficiency testing on both SARS-CoV-2 molecular and serology samples• Performed feasibility and optimization studies for the development of cell-based antigen tests for COVID-19 and Influenza A as well as a serology test for the detection of SARS-CoV-2 antibodies in human serum• Collaborated with R&D team members on assay development strategies and troubleshooting and provided guidance on adhering to regulatory guidelines

IVD/RUO ELISA Manufacturing• Produced and validated ELISA kit components, intermediate and finished goods according to ISO-compliant manufacturing process instructions (MPIs) and standard operating procedures (SOPs) including lyophilization of kit standards and conjugated antibodies.• Performed data analysis, interpretation and summarization• Maintained inventories, records and documentation according to ISO and GMP guidelines• Managed, submitted purchase requests, and stocked consumable inventory items used in production.• Followed quality procedures for existing products, processes and equipment along with assisting with process improvements and product development• Trained in FPLC protein purifications and conjugations• Conducted investigations and troubleshooting as well as interfering substance testing

Assay Development and Validation, Contracted by Quidel• Contributed to the development, validation and troubleshooting of cell-based assays for the detection/quantification of thyroid blocking and stimulatory antibodies• Performed 510(k) studies such as assay precision, reproducibility, LOB, LOD, interfering substances and temperature and time flex• Optimized positive and reference controls; solved an issue causing reference control failures• Performed quality control procedures for R&D produced reagents • Performed data analysis, summarization and assisted in 510(k) report writing • Assisted in production of hybridoma cells and antibodies and trained new hiresTissue Culture• Maintained stable cell lines and created cell banks• Assisted with the screening of clones for the development of a cell-based biosensor for rapid pathogen detectionBacterial Chromosome Engineering• Assisted in creating stable bacterial strains which express large amounts of protein product • Performed plasmid isolation techniques and produced electrocompetent E. coli cells• Performed electroporations, chemical transformations and gel electrophoresis