Led cross-functional teams in the development of PCR-based in vitro diagnostic (IVD) products for personalized healthcare applications. Primary focus areas: Complex companion diagnostic tests (CDx) for Genomics and Oncology. - Managed seven projects, in association with pharmaceutical partners.- Recipient of Own It Award for streamlining development process to expedite delivery of clinical trial assays to pharmaceutical partners. - Successfully managed launches of cobas® KRAS Mutation Test for non-small cell lung cancer in CE markets and cobas® EGFR Mutation Test v2 as a CDx for Tagrisso® and Iressa® in the first-line in US and CE markets.IVD tests for infectious diseases for a novel PCR point-of-care system. Project Manager for IQuum post-acquisition integration/design transfer activities and development of in-house molecular point-of-care assays for the cobas® Liat® platform. Worked collaboratively to build a new Lifecycle Team and transition to full Lifecycle management. - Managed on-time launch in CE markets of first cobas® Liat® assay (C. difficile) developed by Roche.

Led up to three concurrent, 12-15 member, cross-functional teams for high complexity programs addressing improvements to systems consisting of flow cytometry analyzers, cell sorters, high-content bioimaging instruments, in vitro diagnostic (IVD) assays, software, and a sample preparation device in a regulated (FDA, ISO, cGMP) environment. Overcame severe resource limitations associated with a business acquisition by using offshore outsourcing partner to develop and release improved bioimaging data management software package for high-content cell analyzer.Completed large international performance evaluation of improved sample preparation device for clinical cytometer with IVD assay for systems-level 510(k) FDA submission and worldwide release .Developed novel solution for cytometer setup bead problem that averted an expensive software modification.Designed improved software package for high-speed cell sorter in resource-limited environment associated with a business acquisition.Co-led validation of dried HIV CD4 counting reagent with Reagent Development and Manufacturing for new reagent manufacturing process and automated clinical cytometer targeted at developing world markets.

Built multi-disciplinary team from the ground up. Led team in - Design and development of novel disposable microfluidic cartridge prototype with on-board dried reagent diagnostic assay for new point-of-care diagnostic imaging cytometry platform in one year. - Development of new formulation matrix permitting dry-down of on-board reagents for developing world.- Demonstration of diagnostic performance feasibility in an HIV-AIDS CD4 counting application and proof-of-principle for hemoglobin assay.Successfully navigated both cartridge and instrument into division's program portfolio for formal phase-gate product development.Completed International Institute for Learning, Inc. Project Management Certificate Program: The Kerzner Approach to Project Management Excellence.

Led new business venture technical program for cell therapy technology development focused on transplantation, graft vs. host disease and autoimmune Type 1 diabetes applications. Built inter-divisional team and led translation of basic medical research findings from key opinion leaders' laboratories into a well-documented small-scale production process for human regulatory T cells. Led development of QC assays to monitor cell identity, purity, viability, and potency. Integrated and aligned process development activities of in-house groups at three different locations with a contract manufacturing organization and demonstrated feasibility of clinical scale-up of the bioprocess.

Rebuilt, restructured, and enhanced organizational effectiveness of a key product development group in an environment requiring on-time, on-budget delivery of multiple concurrent high complexity programs for the company's major IVD and life sciences research cell analyzers, cell sorters, sample preparation devices, diagnostic assays, and software. Met or surpassed business-critical target dates for product launch of two new instruments, one of which received an award from the Industrial Designers Society of America and Business Week. Also released new and improved clinical and research software packages and upgrades to four existing instruments. Overhauled documentation and built a culture based on Six Sigma principles. Led generation of systems performance data for European CE marking and FDA 510(k) submissions.Awarded Six Sigma Green Belt Certification for cost/efficiency improvements in a fluorescent monoclonal antibody reagent manufacturing process.

Re-envisioned and re-focused company's efforts to address a large market opportunity in sepsis. Led cross-functional, inter-divisional team in evaluation of biomarkers for early identification of patients at risk for sepsis. Successfully designed and completed clinical feasibility study with a key opinion leader, resulting in an issued US patent (7,465,555 B2) for a predictive biomarker-based patient classification algorithm.Led group in standardization and optimization of intracellular cytokine biomarker profiling assays to characterize and monitor antigen-specific T cell immunity to vaccines. Collaborated with external investigators and introduced assays into Phase I/II clinical trials to demonstrate proof-of-principle in ex vivo monitoring of patient immune responses to HIV-AIDS and cancer vaccines.Developed and released new flow cytometry reagents and a standardized assay for detecting intracellular inflammation biomarkers (COX-1, 2) for non-steroidal anti-inflammatory drug (NSAID) and Type 1 diabetes research.

Evaluated new technology opportunities and managed intellectual property estate. Improved company's strategic position prior to sale by evaluating potential candidate technologies for in-licensing/partnering and advising outside legal counsel on scientific aspects of core technology patent language and claims defensibility, with estimated impact of $7M. Consolidated intellectual property portfolio reducing legal and administrative costs in excess of 10%.

Built cell biology/immunology organizational capability for product characterization and applications development of lead product and product pipeline. Performed a variety of ancillary functions to meet company needs and further its objectives. Recruited, trained, and led team in characterization of Ontak for FDA Investigational New Drug (IND) Applications, Biologics License Application (BLA), and publications with key opinion leaders.Developed and standardized cell-based assays for lead product structure optimization, potency, mechanism of action (receptor binding, kinetics, cell death), and immunotoxicity. Led monoclonal antibody group in critical re-design of immunoassays for product integrity and purity.Collaborated with extensive network of academic and clinical thought leaders to facilitate technology exchange, applications development, and joint research publications in oncology, HIV-AIDS, and autoimmune diseases such as rheumatoid arthritis, lupus, and diabetes.Coordinated selection of efficacy endpoint assays for an Ontak Phase I/II HIV-AIDS clinical trial with seven external laboratories and a Clinical Research Organization. Also coordinated sample shipments, data analysis, and preparation of the final clinical trial report.

Responsible for cell biology-immunology start-up operations in new company. Evaluated early-stage research projects for scientific fitness and commercial potential, resulting in re-focusing of product development effort on recombinant fusion toxin proteins.Successfully generated cash for start-up with a Small Business Innovation Research (SBIR) grant for the company’s first fusion toxin for melanoma. Designed, equipped, and directed a cell biology-immunology laboratory and animal facility from the ground up. Introduced and developed in vitro assays and in vivo cancer models to evaluate product safety and efficacy.