Led a team providing on-market product support and instrument field service for gene expression profiling products.• Performed gap analyses of complaint handling processes, identified and implemented improvements to address gaps.• Reduced average time to close complaints 50% in one year, and reduced complaint review board meeting times by 50%.

Led teams totaling 12 to 125 people (2-13 managers) developing (under design control) and supporting IVD immunohistochemistry (IHC), immunocytochemistry, and in situ hybridization (ISH) assays for formalin-fixed, paraffin embedded tissue and liquid-based (cytology) samples on computer interfaced electromechanical staining platforms. Project scopes covered product and process feasibility through post-launch support.• Teams launched numerous new or significantly improved FDA Class I, II, and III assays, and CE marked IVD (CE-IVD) assays.• Managed budgets, resources, timelines, interdepartmental alignment, conflict resolution, and aligned group objectives with company goals.• Merged four assay development teams with different technical and product line expertise into one assay development group with aligned goals and performance expectations. • Implemented personnel skillset tracking and gap analyses to identify current and future needs. Implemented training programs and targeted hiring to address gaps identified.• Implemented a decentralized on-market product support model where the teams who developed the products investigated and resolved technical issues.• Built close working relationships with leadership of the Research and Assay Transfer teams to ensure smooth technology and product transfers into Development and out to Manufacturing.• Worked with cross-functional teams to establish or improve processes for product development, personnel promotion, resource utilization tracking, product lifecycle management implementation, and process validation (divisional standard).

Led teams manufacturing (GMP facility) ISH probes, IHC primary antibodies, probe and antibody detection reagents, and ancillary reagents for IVD use, totaling up to $200 million in annual sales.• Maintained greater than 98% product availability while staying within 5% of budget and delivering ≥5% annual cost reductions using lean manufacturing methods.• Led the establishment of electronic Device Master Records.• As the Manufacturing lead, worked with cross-functional project teams to transfer new products from Development to Manufacturing. Wrote the majority of the Manufacturing section of a successful PMA submission.

Led teams of up to 12 direct reports that manufactured and supported probes, detection system reagents, and control slides for IVD IHC and ISH assays, with emphasis on technical issues.• Maintained greater than 98% product availability.• Managed the Histology lab to supply tissue slides for external and internal customers.• As the Manufacturing lead on cross-functional development teams, executed or managed all Manufacturing activities of new product transfers for 13 molecular probes (CE-IVD and ASR) and one detection kit from Development to Manufacturing.• Hired and trained personnel, managed performance, and wrote and delivered annual reviews.

Provided daily production and new product transfer support for dye-based histology stains, IHC primary antibodies, and ancillary reagents for IVD use.• Maintained on-market product availability for numerous products. Wrote / reviewed process validation protocols and reports, out of specification and nonconformance reports, temporary deviations, and corrective and preventive actions.• As the Manufacturing lead on cross-functional teams, transferred three new antibodies (Class I and PMA) and six new high volume dye reagents from Development to Manufacturing. Wrote Manufacturing sections of all project documentation.

Supported the manufacture and development of IVD assays for blood coagulation.• Performed daily production support, customer complaint investigations, new raw material qualifications, and new product transfers (Class II) from R&D to Manufacturing.• Wrote, reviewed, and trained personnel on SOPs, manufacturing, QC testing, and raw material receipt documentation. Supervised department (six scientists) in regular manager’s absence.

Conducted structure and function studies of the flavoenzyme thioredoxin reductase from E. coli using X-ray crystallography, rapid reaction kinetics, UV/vis and fluorescence spectroscopy, and dynamic light scattering