Experience

Gritstone bio

• United States
• Biotechnology Research
• 100 - 200 Employee

• Director Of Quality

  • Aug 2021 - Present

  Cambridge, Massachusetts, United States



Foundation Medicine

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Quality Assurance: Design Controls

  • Mar 2020 - Aug 2021

  Cambridge, Massachusetts

• Sr. Manager, Quality Assurance: Design Controls

  • Oct 2018 - Mar 2020

  Cambridge, Massachusetts, United States



Integra BioCompliance, LLC

• Owner / Principal Consultant

  • Jun 2011 - Aug 2021

  Greater Boston Area



Jordi Labs

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• Director of Quality

  • Nov 2017 - Jul 2018

  Mansfield, Massachusetts



Cambridge Biomedical Inc.

• Manager, Research and Development/Site Study Director

  • Jul 2010 - Jun 2011

  • Management of all scientific operations within CRO environment • Direct assay development team in the design, development, and validation of clinical diagnostic assays (HPLC, ELISA, Cell-Based, Viral Neutralization, RIA, etc) under CAP/CLIA and GLP compliance • Direct the day-to-day assay development/validation activities of Clinical R&D staff (MD’s, PhD’s, Research Technicians, Junior Personnel) • Developed and validated Immunoassays (14 to date) under GLP and FDA guidelines… Show more • Management of all scientific operations within CRO environment • Direct assay development team in the design, development, and validation of clinical diagnostic assays (HPLC, ELISA, Cell-Based, Viral Neutralization, RIA, etc) under CAP/CLIA and GLP compliance • Direct the day-to-day assay development/validation activities of Clinical R&D staff (MD’s, PhD’s, Research Technicians, Junior Personnel) • Developed and validated Immunoassays (14 to date) under GLP and FDA guidelines • Writing, reviewing (as Management or Technical reviewer) of SOPs, Validation Protocols, Validation Reports, and other documents • Perform role as Site Study Director for several key GLP projects in support of Contract Research efforts • Support Sales/Marketing team functioning as Scientific Technology Leader in support of new business opportunities • Prepare abstracts and presentations; Attend and present at scientific meetings (Keystone Symposia, gtcBiomarker, MassBio) Show less



Medical Diagnostic Laboratories, LLC

• Division Head / Team Leader, Antigen Discovery

  • Mar 2006 - Jul 2010

  • Designed, directed, and managed all projects within the Antigen Discovery team • Managed Antigen Discovery Division budget • Actively engaged in laboratory research while performing functions and duties as Division Head • Managed team of Ph.D.s, technicians, and student interns in the performance of all projects and tasks. • Functioned as business development liaison to identify and foster commercial partnerships for manufacturing and marketing of antigens and assays developed by… Show more • Designed, directed, and managed all projects within the Antigen Discovery team • Managed Antigen Discovery Division budget • Actively engaged in laboratory research while performing functions and duties as Division Head • Managed team of Ph.D.s, technicians, and student interns in the performance of all projects and tasks. • Functioned as business development liaison to identify and foster commercial partnerships for manufacturing and marketing of antigens and assays developed by Antigen Discovery team. • Worked closely with IP attorney in the drafting and submission of patent applications and in the preparation and processing of MTAs, NDAs, and related documents • Served on High-Throughput Screening subcommittee • Served as Search Committee Chairperson for R&D Department Show less



Medical Diagnostic Laboratories

• Research Immunologist

  • Mar 2006 - Jun 2006

  • Successful identification of novel antigens and development of diagnostic assays for detection of IgG and IgM antibody responses to tick-borne pathogen Bartonella henselae • Managed and provided scientific support to Immunology department members: (identification, cloning, recombinant expression/purification) of antigens for development of assays • Promoted to Team Leader, Antigen Discovery Division (new team) as a result of my successful efforts to streamline and refine Immunology… Show more • Successful identification of novel antigens and development of diagnostic assays for detection of IgG and IgM antibody responses to tick-borne pathogen Bartonella henselae • Managed and provided scientific support to Immunology department members: (identification, cloning, recombinant expression/purification) of antigens for development of assays • Promoted to Team Leader, Antigen Discovery Division (new team) as a result of my successful efforts to streamline and refine Immunology team projects. Show less



Ingenuity Systems

• Field Applications Scientist

  • Aug 2005 - Feb 2006

  • Provided pre- and post sales applications support for Ingenuity’s web-based molecular pathways analysis tools • Designed, prepared, and presented scientific presentations to customers • Conducted presentations at scientific meetings



MidAtlantic Territory

• Sales Representative

  • May 2004 - May 2005

  • Successfully managed 1100 Academic and Industrial accounts in the Mid-Atlantic region (PA, DE, NJ, NYC) • Successfully grew sales in academic accounts by 19% during 2004 • Exceeded sales goal in Academic accounts during entire tenure with USB • Exceeded sales goal in Academic accounts in Q1 (2005) by 37.7% • Exceeded sales goal in Industrial accounts in Q1 (2005) by 5.8%



Napro Biotherapeutics (Genomics Division)

• Genomics Consultant

  • Feb 2004 - Aug 2004

  Provided scientific expertise on NaPro's proprietary genomics technology to prospective buyers following company downsizing prior to shut-down of operations.

• Scientist II

  • Feb 2003 - Feb 2004

  • Responsible for day-to-day operation of the gene isolation services laboratory, including carrying out protocols for isolating full length DNA clones for clients, management of laboratory personnel, data management, designing/refining SOPs, and assisting with budgetary decisions • Used NaPro's core technology employing the ability of recombinase proteins to form a sequence-specific DNA heteroduplex between a single-stranded DNA (ssDNA) probe and a double-stranded (dsDNA) target, to isolate… Show more • Responsible for day-to-day operation of the gene isolation services laboratory, including carrying out protocols for isolating full length DNA clones for clients, management of laboratory personnel, data management, designing/refining SOPs, and assisting with budgetary decisions • Used NaPro's core technology employing the ability of recombinase proteins to form a sequence-specific DNA heteroduplex between a single-stranded DNA (ssDNA) probe and a double-stranded (dsDNA) target, to isolate full-length clones from cDNA and genomic DNA libraries • Successfully launched gene isolation services business, employing proprietary cloning technology to isolate full-length cDNA clones • Refined SOPs for cloning full-length genes, leading to a reduction in the time frame for project completion from approximately 4 weeks to 8 working days • Functioned as a technical expert on the gene isolation services business development team. Worked to develop and support new and existing business by interacting with clients from academic, biotechnology, and pharmaceutical companies



GE HealthCare

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Field Applications Specialist

  • Oct 2000 - Nov 2002

  • Responsible for conducting the installation, training, and demonstration of proteomics based instrumentation (Ettan Spotpicker), Scanners (Typhoon, Storm, PDSI, Fluorimager), and imaging software (Imagemaster, Fragment Analysis, FluorSep, ImageQuant). • Provided pre and post-sales technical support (hardware, software, applications) for proteomics and imaging systems (scanners) clients. • Supported sales and marketing teams by providing technical presentations and seminars at customer… Show more • Responsible for conducting the installation, training, and demonstration of proteomics based instrumentation (Ettan Spotpicker), Scanners (Typhoon, Storm, PDSI, Fluorimager), and imaging software (Imagemaster, Fragment Analysis, FluorSep, ImageQuant). • Provided pre and post-sales technical support (hardware, software, applications) for proteomics and imaging systems (scanners) clients. • Supported sales and marketing teams by providing technical presentations and seminars at customer sites, professional conferences, trade shows, and within the applications laboratory at Amersham. • Played a key role in the successful launch of the proteomics line of instrumentation as the only Proteomics Field Applications Specialist covering the entire North American territory from November 2000 until January 2002. During this time, was also responsible for microarray and Scanner Applications support for the MidAtlantic and, for a six-month period, the Southeast region of the US. • Successfully completed Consultative Selling Skills Training course, April 2002 Show less



West Virginia University School of Medicine

• Research Assistant Professor/Principal Investigator

  • Apr 1998 - Oct 2000

  • Independent Investigator responsible for designing, planning, and management of laboratory research projects. • Responsible for obtaining grants, data analysis, publication of original research. • Supervised and managed the work of laboratory personnel. • Successfully designed and carried out research project to uncover differentially expressed genes in human bronchial epithelial cells transformed with NNK, a tobacco-specific carcinogen. This work led to the discovery of the… Show more • Independent Investigator responsible for designing, planning, and management of laboratory research projects. • Responsible for obtaining grants, data analysis, publication of original research. • Supervised and managed the work of laboratory personnel. • Successfully designed and carried out research project to uncover differentially expressed genes in human bronchial epithelial cells transformed with NNK, a tobacco-specific carcinogen. This work led to the discovery of the down-regulation of the gene encoding Ubiquinone, an electron transport chain polypeptide. Our results provided key suppportive evidence of the mitochondria as a target of tobacco-specific carcinogens. • Awarded grant from The American Cancer Society entitled, "Differential Display PCR Cloning of Taxol-Responsive Genes in Immortalized, Carcinogen-Transformed Human Lung Cells". • Collaborated on cell-signaling project with colleagues at the Mary Babb Randolph Cancer Center.

• Senior Research Associate

  • Oct 1995 - Apr 1998

  • Investigated the role of heavy metal-induced gene expression in human kidney cells • Responsible for culture and maintenance of human kidney cell lines • Cloned and sequenced the cDNA for Metallothionein III from human kidney cells. This was the first evidence demonstrating the expression of this gene, widely accepted as being down-regulated in the brain tissue of patients with Alzheimer's disease, in nonbrain tissue • Cloned and sequenced the full-length cDNA for HMRG1 (Heavy Metal… Show more • Investigated the role of heavy metal-induced gene expression in human kidney cells • Responsible for culture and maintenance of human kidney cell lines • Cloned and sequenced the cDNA for Metallothionein III from human kidney cells. This was the first evidence demonstrating the expression of this gene, widely accepted as being down-regulated in the brain tissue of patients with Alzheimer's disease, in nonbrain tissue • Cloned and sequenced the full-length cDNA for HMRG1 (Heavy Metal Response Gene 1), a novel 1.7 kB cDNA up-regulated in kidney cells exposed to heavy metals • Co-Principal investigator on a $1.5 million dollar NIH grant entitled, "Differential Display of Genes Mediating Hg2+ Toxicity" • Conducted molecular biology workshops for postdoctoral fellows and junior faculty



National Institutes of Health (National Heart, Lung, and Blood Institute)

• Intramural Research Training Fellow

  • Oct 1993 - Oct 1995

  • Postdoctoral training was done in the laboratory of Dr. E.D. Korn, (member of the National Academy of Sciences) • Cloned and sequenced the cDNA for the entire catalytic domain of Myosin I Heavy Chain Kinase from Acanthamoeba. The cloning of the cDNA encoding this kinase had been an unmet challenge for almost a decade prior to my joining the laboratory and taking on this research project. The results of this work were published in the Journal of Biological Chemistry