Timothy Foley

Experience

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  Quest Diagnostics

  Jan 1986 - Jan 1992

  Co-managed a large multidisciplinary diagnostic clinical chemistry and immunochemistry laboratory with up to 18 FTE. Special chemistry technologist performed diagnostic testing using various analytical platforms to include but not limited to protein, lipoprotein, hemoglobin electrophoresis, chromatography, UV/VIS/FLR, automated chemistry analyzers, IFA, ELISA, immunofixation, immunoelectrophoresis, nephlometric quantification of individual proteins, laboratory-developed manual chemistry methods and various serological techniques. Trained on a minimum of 100 different SOPs.

  • Assistant Manager Special Chemistry Laboratory

    Jan 1988 - Jan 1992

  • Medical Technologist Special Chemistry Laboratory

    Jan 1986 - Jan 1988
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  Quest Diagnostics

  Jun 1993 - Sept 1995

  Medical Technologist II- Laboratory Supervisor

  Managed weekend stat clinical chemistry, hematology, urinalysis, coagulation, toxicology and fertility endocrinology testing including phlebotomy services.

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  Massachusetts Health Research Institute (MHRI)

  Dec 1993 - Jul 1997

  Clinical Chemist - Newborn Screening Laboratory/NENSP

  Oversaw the hemoglobinopathy and metabolic laboratory screening laboratories in the New England Newborn Screening Program. Implemented workflow improvements and an HPLC reference method for amino acid quantification using flourescence detection.

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  Northeastern University

  Jan 1994 - Jan 1995

  Adjunct Faculty, Department of Medical Laboratory Science, Bouve College of Health Sciences

  Instructor undergraduate courses in clinical chemistry and instrumentation.

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  New England Newborn Screening/University of Massachusetts

  Jul 1997 - Jan 2005

  Supervisor Laboratory Analysis and Test Services

  Oversaw the hemoglobinopathy and metabolic laboratory screening laboratories in the New England Newborn Screening Program. Responsible for accurate and timely test result reporting and interpretation for physicians. Developed all experimental and statistical validation procedures for FIA MS/MS for expanded metabolic screening for amino acidopathies and fatty acid oxidation defects. Expanded screening initiated in February 1999. Implemented statistical QC procedures and an inter-laboratory sample swap program to monitor MS/MS precision and accuracy. Show less

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  Sanofi

  Feb 2005 - Apr 2017

  • Senior Scientist, Biomarkers and Clinical Bioanalyses, Translational Medicine and Early Development

    Mar 2016 - Apr 2017

  • R&D Manager Clinical Mass Spectrometry, Clinical Laboratory Science, Cell and Molecular Therapeutics

    Jan 2008 - Mar 2016

  • Staff Scientist II, Clinical Laboratory Sciences, Cell and Molecular Therapeutics

    Feb 2005 - Jan 2008
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  BERG Health

  Mar 2011 - Aug 2013

  Scientific Consultant Clinical Diagnostics and Bioanalysis

  Development of quality systems for CLIA and Massachusetts State clinical laboratory licensure for Berg Diagnostics. Consulted on clinical mass spectrometry assay design, development of quality requirements, and validation strategies for LC/MS/MS assays used in pharmacokinetic and diagnostic indications, process development, and technical writing. Wrote over 50 SOPs and associated documents and implemented a laboratory safety compliance program. Provided laboratory information management system consulting to include final vendor selection. Designed experiments and performed statistical analyses required for complete CLIA and bioanalytical assay validation for a novel 25-OH vitamin D2 and D3 LC/MS/MS assay. Technical consultant for on-site support during CLIA survey and inspection. CLIA certificate of compliance awarded 2012. See the Berg Diagnostics press release in 2012 for details: www.berghealth.com. Show less

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  KCAS Bioanalytical & Biomarker Services

  Jan 2014 - Oct 2015

  Senior Consultant - CLIA and Diagnostic Testing Compliance

  Development of quality systems for CLIA and Kansas State clinical laboratory licensure for KCAS Bioanalytical & Biomarker Services. Performed an audit of the KCAS laboratory facility and developed remedial SOPs, quality policies, and a global quality plan for KCAS for federal CLIA compliance. Consulted on development of quality requirements, statistical methods, and experimental designs for complete LC/MS/MS assay validation studies required for diagnostic testing.

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  Waters Corporation

  May 2017 - Jul 2021

  Responsible for business development and instrument configuration and applications consulting, support, and sales for clinical diagnostics, toxicology, and forensic science customers in the Greater Boston and New York City Metro areas.

  • Business Development Manager- Clinical and Forensics Markets

    Jan 2021 - Jul 2021

  • Senior Clinical and Forensics Specialist

    May 2017 - Dec 2020
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  MedTherapy Biotech

  Nov 2018 - Aug 2021

  Consultant Bioanalysis and Quality

  Member of the executive committee.

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  LabQ - Most Innovative Clinical Lab

  Aug 2021 - Mar 2022

  LC/MS/MS Assay Development Consultant
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  Takeda

  Aug 2021 - now

  Responsible for developing and implementing bioanalytical chemistry strategy for multiple global development programs, including vendor selection, new technology evaluation and oversight of assay development, validation, transfer and clinical bioanalysis in late stage clinical development for novel therapeutics at Takeda.

  • Associate Scientific Director, Center of Excellence for Biomarker Science & Technologies

    Aug 2021 - now

  • Principal Bioanalytical Chemist, Clinical Biomarker Innovation and Development

    Aug 2021 - Jan 2023