Daniel J. Pollart

About Daniel J. Pollart

Manager and Scientist in Molecular Biology and Organic Chemistry with expertise in all stages of the transition of new technologies into successful commercial products for the diagnostics and pharma industries, including design, development, verification, transfer to mfg/ops, product placement and support. Lead or member of globally diverse, cross-functional and multi-disciplinary project teams and alliances that provide solutions to complex technical, logistical and communication issues.Core Competencies:Development of Diagnostic Platforms and Assays, including design, verification and scale-up of novel reagents and detection chemistries to meet new product specifications; transfer to internal operations and external manufacturing partners; product placement and commercializationSupport of Global Customers and Commercial Products through the investigation and resolution of complaints and non-conformances regarding the performance of regulated (IVD, CE) products in collaboration with internal and external manufacturers, marketing, QA, regulatory affairs and technical support specialistsSynthesis of Small Molecules, Natural Products, Functionalized Oligonucleotides and Antibody Conjugates with targeted therapeutic and diagnostic applicationsSample Preparation and Analysis of Clinical Specimens and Cultured Cells for protein, antibody, antigen and nucleic acid analytes; DNA amplification and detection, PCR optimization, DNA sequencing and fragment analysisTechniques and Instrumentation: Nucleic acid amplification and detectionImmuoassaysHPLCGel and capillary electrophoresisNMRSpectrophotometryMS (ES, MALDI-TOF)Solid-phase coupling and array productionProtein conjugationDye modification & couplingCell cultureProject managementExperimental designStatistical analysisRisk and root cause analysisAdditional Experience includes supervision/development of personnel, data management and analysis, reporting, documentation, and oral presentations.

Experience

1. Design Quality Assurance - Point of Care and Genomics & Oncology

   Roche

   Oct 2014 — Present · Pleasanton, CA, US

   Provide strong interface with Quality Management, Regulatory, Research, Development, and Clinical Operations to assure all products and processes are in compliance with company standards and quality systems.Provide Quality Functional Leadership to local Life Cycle Teams and ensure the teams fulfill all quality and regulatory requirements. Develop and drive a work culture committed to compliance, quality and customer focus.Development and support of in vitro diagnostic products for detection of respiratory disease and other viral and bacterial infections, cardiovascular disease, noninvasive prenatal testing and oncology.

Education

• UC Santa Barbara

  Doctor of Philosophy (Ph.D.), Organic Chemistry

• Fairfield University

  Bachelor of Science (B.S.), Chemistry

• UC Irvine

  Post-doctoral Fellowship, Organic Chemistry

Skills

• Personalized Medicine
• Validation
• Mass Spectrometry
• Biochemistry
• Drug Discovery
• Organic Synthesis
• Rca
• Capa
• Multiplex Pcr
• Natural Product Synthesis
• Nanodrop
• Nmr Spectroscopy
• Life Sciences
• Blood Screening
• Ngs
• Rna Isolation
• Product Development
• Technology Transfer
• Root Cause Analysis
• Cell Culture
• Sample Preparation
• Pcr
• Global Compliance
• Platform Development
• Molecular Biology
• Assay Development
• Microbiology
• Dna Extraction
• Quality Assurance
• Lifesciences
• Purification
• Product Support
• Hplc
• Organic Chemistry
• Elisa
• Immunoassays
• Electrophoresis
• Qpcr
• Dna
• R&D