Responsible for developing and implementing our biomarker strategy, in clinical studies.

Performing and designing clinical Flow Cytometry assay development and Fit- For-Purpose analytical validation and implementation for Biologics, and small molecule• Oversee in-house clinical sample analysis and assay validation• Providing and contributing in clinical protocol for sample collection and shipping instruction, trouble shooting and data delivery within biomarker plan and timeline for clinical team• Scientific lead assigned to discovery, early clinical development and biomarkerteam projects and providing assay and technical expertise• Managing the operational laboratory responsibilities, and implementation of new SOPs• Participate in meetings with global regulatory agencies to provide technical expertise• Lead in the selection of appropriate diagnostic platforms for the execution of biomarker strategies

Cambridge Biomedical Inc. is a specialized CRO serving the diverse requirements of the CRO and Biopharmaceutical/Pharmaceutical and Diagnostic markets, utilizing its multi-platform laboratory science capabilities and state of the art systems and procedures. We provide our clients with assay development, assay validation and testing services in support of their clinical trial and pharmaceutical development objectives. Our breadth of experience in laboratory science uniquely positions Cambridge Biomedical to serve as trusted advisor to our clients and provide value-added services beyond the requirements of the project. We are committed to developing each service engagement into a long term relationship. SpecialtiesAssay Development, Assay Validation, Clinical Trial Testing, GLP Systems for Pharmaceuticals and Biotech, PCR, RIA, Regulatory consulting, ELISA, HPLC, CLIA, CAP, Luminex, Bioanalytical assay, Flow cytometry, MSD

• Designed, developed and implemented assays for detection target biomarker.• Developed translational based approaches to differentiate research projects within immune and inflammatory diseases • Designed and executed innovative experiments in the areas of cell biology, flow cytometry and multiplex analysis of soluble inflammatory mediators.• Participated in projects for translational medicine to develop early clinical strategies for lead programs• Independently prepared and communicated technical reports, publications and oral presentations.• Delivered updates to senior level management in context of overall project goals.• Kept up to date of relevant literature and develop visibility outside of functional area.• Assumed responsibility for direct reports as needed including managing, mentoring and developing scientific staff.

• Led the main project in adaptation of HCV/HIV to KIR-associated Immune pressures, resulted in published Abstract and presentation at Keystone Symposia Colorado 2012. • Managed database and phylogenetic analysis of HCV related immune response. • NK cells phenotyping and receptor interactions.

• Led and conducted multiple experiment in studying immune cells function in Lyme Arthritis and Rheumatoid Arthritis, (main project)resulted in 2 published papers. • Supported postdocs and assisted in design and executing the experiments.(co-authoring in publications) • Participated in weekly planning of scientific seminars and meetings. • Assisted in general day to day laboratory routines.

• Investigated cell-mediated immune responses to Clostridium difficile Toxins A and B in patients with Clostridium difficile associated diarrhea. • Characterized the phenotype and function of T regulatory cells in intestinal inflammatory diseases (IBD). • Investigated T cell pathways in IBD animal models. • Developed a novel experimental animal model to study C. difficile associated disease, immune response and recurrence. • Studied T cell mediated immune responses in murine inflammatory models and conducted assays to study immune responses to recombinant protein vaccines in animal models. • Studied immune cells interaction and activation in IBS.

• Investigated the role of specific T cell subsets and NK cells in patients with pulmonary inflammation including Sarcoidosis, Asthma and COPD. • Executed experiments to identify inflammatory mediators, chemokine and cytokine receptors in brochoalveolar lavage and peripheral blood cells in patients and healthy individuals by utilizing Flow cytometric assays. • Dissertation Thesis: T LYMPHOCYTE AND NK CELL FUNCTION IN PULMONARY INFLAMMATION IN SARCOIDOSIS

• Investigated T cell receptor variable genes in patients with Amyotrophic Lateral Sclerosis (ALS) in relation to the disease resulted in 1 published paper.• Conducted database patient screenings and questioner for the study

• Conducted Quality control for medical devise , diagnostic tracers • Measured environmental analysis, microbiology and fungi analysis, • Managed and expedited approval of product release for Pharma and technical institutes.• Assisted in documentation of regulatory submissions according to ISO 90000• Worked according to GLP and GMP. • Project management and regulatory related documents.