James Brinkman

Provided technical support and training for global customers, distributors and contract suppliers of the Thermogenesis AutoXpress (AXP) stem cell collection platform, along with the Cryo Seal and TPD surgical wound care platforms for the European market. This support includes conducting on site training, validation, troubleshooting and IQ/OQ procedures

Performed on site clinical training and education of institution staff for major commercial plasma accounts throughout the United States on the Haemonetics PCS2 automated collection equipment. Planned and executed all facets of on site customer training from up front contacts with the customer institution to final wrap up, and certification of center staff.

Marketed and implemented the GTI line of histocompatability, (HLA), coagulation and blood bank products to hospital laboratories, reference laboratories and blood banks throughout the Northeast United States and Canada. Managed company activities at major scientific conferences and trade shows (ASHI, AABB, ASH ) . Set up exhibit booth and marketed product to conference attendees.

Performed manufacturing, testing and troubleshooting functions, on Abbott Diagnostics’ line of anticonvulsant and antibiotic MEIA and FPIA drug monitoring immunoassays on the Abbott AxSYM and TDx – TDx/FLx platforms per FDA, CBER and cGMP requirements. Created and modified new and existing manufacturing and testing documents per CAPA and Quality System guidelines.

Performed stability and stress testing and data analysis for the European launch of the Hepatitis C MEIA assay for the PRISM automated blood screening analyzer. Analyzed all components of the assay to determine their suitability for use in the final product in order to maximize shelf life without compromising product performance. Presented results to the design team and management.

Cytogenetics Cell/Molecular Biology Pathogenic Microbiology Virology