CORE COMPETENCIES & TECHNICAL SKILLS
Quality:
DMPK, Bioanalytical SME, Analytical Method Validation, GMP 21 CFR Part 210/211 (certified), ISO 13485 (certified), GCP, ISO 14155, GLP (certified), data integrity, Biocompatibility studies, microbial testing of water. endotoxin, bioburden, TOC testing of water, immunoassays, Design Master Files (DMF), Design History Files (DHF), CAP/CLIA procedures, ICH guidelines, 483 resolution, CAR, CAPA (writing, reviewing, editing, effectiveness analysis, training), data integrity, Bioanalytical Method Development, GMP auditing, deviation (NCR) investigation, gap analysis, software (Word, Excel, Watson™, Analyst™, Agile, Trackwise™, Empower™, Chromeleon™, small molecule pharmaceuticals, biologicals, IQ/OQ/PQ, Technology Transfer, API
R&D:
Assay development, technology transfer, bioanalytical data analysis, method development/validation, consummate communication (written, verbal) and presentation skills, ELISA, cell-based bioassays, Karl Fischer titration, UV Spectrophotometry, Protein concentration by UV spectrometry, sub-visible particles testing by light obscuration/microscopy, HPLC, TLC, Microbial, Capillary Isoelectric Focusing (iCEF), IEF, SDS-PAGE, cell culture, CRO and Diagnostic team management, immunoassays, antigen discovery, antibodies, PK/PD studies
Product Development and Commercialization:
Twenty-one patents (Domestic and International), managing commercial partners, product commercialization, Intellectual Property (IP), innovative, collaborative and creative.
EDUCATION & POST-DOCTORAL TRAINING
PhD, Molecular and Cellular Biology
Graduate School and University Center of the City University of NY: 1993
M’Phil, Biology
Graduate School and University Center of the City University of NY: 1993
M.A., Biology
City University of NY (Brooklyn College): 1991
B.A., Biology
City University of NY (Brooklyn College): 1989
Postdoctoral Research Fellowship
West Virginia University School of Medicine, Department of Experimental Pathology: 1995-1997
Intramural Research Training Fellowship
National Heart, Lung, and Blood Institutes of the NIH, Laboratory of Cell Biology: 1993-1995
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CAREER HISTORY & ACCOMPLISHMENTS
QUALITY EXPERIENCE:
Independent Quality Consultant
June 2011- Present
Bioanalytical /DMPK Consultant, Development Insights
October 2017 - Present
Remote Assignments
- Function as DMPK/Bioanalytical Subject Matter Expert (review of data, validation protocols, validation reports)
*Director of Quality, Jordi Labs, LLC
November 2017 – June 2018
Mansfield, MA
- Successfully built a GMP-compliant QMS in a previously non-regulated work environment (Analytical Testing Laboratory)
- Performed GAP analysis to assess 21 CFR 210/211 and 21 CFR 820 readiness immediately upon hire
- Successfully developed and implemented plan of action to build a 21 CFR 210/211 and 21 CFR 820 compliant QMS
- Performed method validations under GMP
- Wrote or revised all Quality SOPS
- Conducted and documented (in electronic data management system) laboratory investigations (OOS, Deviations, CAPA)
- Performed IQ/OQ for audit trail programs onto all GMP-validated instruments
- Wrote temperature-mapping protocols, and carried out the mapping of GMP refrigerators and freezers.
- Directed all Quality activities in an ISO 9001, GMP, and non-GMP work environment
*Full-time Employee
Senior Independent Consultant, APEC
Sept 2017 – October 2017
Oklahoma City, OK
In response to 483 Warning Letters:
- Performing method assessments and gap analysis of Cleaning Validation Methods (RP-HPLC, Conductivity, Endotoxin, Bioburden)
- Writing Validation Protocol for TOC (Total Organic Carbon) testing
- Writing Validation Protocol for Microbial Assay for testing of purified and WFI water
cGMP Quality Auditor, Black Diamond Networks
August 2017 - Sept 2017
Oakdale, MN
- Served as Lead Auditor for GMP supplier audit with emphasis on Sample Handling, Quality Systems (OOS / OOT, CAPA’s, Deviations, Internal Audits), Equipment Qualification/Calibration/PM, Reference Standard Storage and Qualification, Training, Production, Quality Control, Data Integrity, Contract Manufacture and Analysis, Customer Complaints & Recall, QMS, and Client commercial supply chain
Senior Independent Consultant, PAREXEL International
May 2017 - June 2017
Chennai, India
- Performed Analytical Batch Review and Certification in response to 483 for pharmaceutical client in India
Senior Consultant, Verta Life Sciences
April 2017 - May 2017
Global
- Served as Lead Quality Auditor in the performance of global CMO site-qualification audits for confidential small oral solid dosage Pharma client (QMS review included CAPA, Deviation (NCR) Investigations, Training, Change Control, Quality System Documentation, SOPs, and Policies)
- Served as Biologics SME (provided expertise and guidance on data relating to enzyme structure, expression, biological activity, purification, and drug delivery, of client’s proprietary peptide for celiac disease)
ISO Compliance and Quality Systems Management, Vechtor Life Sciences
GI Dynamics, Inc.
May 2016 - March 2017
Lexington, MA
Boston, MA
- Served as SME for the rebuilding of the Quality Management System at a Medical Device Company (Developer and manufacturer, and distributor of the endoscopically-implanted EndoBarrier™ Class IIB device)
- Ensured site readiness in accordance with BIMO requirements in preparation for clinical trial of modified medical device
- Review, auditing, and remediation of Design Master Files (DHF) and Design History Files (DHF) in preparation for ISO audits and 510(k) Pre-Submission
- Review of CAPAs, Deviations (NCR), Root Cause Analyses, and assessment of CAPA effectiveness (for CAPAs written in response to CARs received from Notified Bodies)
- Performed Risk assessment and analysis to address concerns by Notified Bodies and Competent Authorities
- Addressed concerns by Notified Bodies and Competent Authorities related to deficiencies in the QMS
- Played key role in transferring Notified Bodies as part of the Quality System realignment
- Audited and GAP analysis of Technical documentation in preparation for Notified Body and FDA inspection
- Audited clinical studies to assess compliance with GCP, ISO 13485, and ISO 14155
- Performed GAP analysis, and worked to update QMS, in preparation for transition from ISO 13485:2003 to ISO 13485:2016
- Wrote and edited CER and other Clinical Reports
- Successfully utilized Agile project management software for document, data, and project management
cGMP Quality Auditor, Qualifactor Solutions
June 2016 - June 2016
San Diego, CA
- Served as Lead Auditor for GMP audit of Sherpa Packaging facilities (San Diego, CA) with emphasis on Production, Quality Control, Data Integrity, Contract Manufacture and Analysis, Customer Complaints & Recall, QMS, and Client commercial supply chain
Senior Consultant, PAREXEL
March 2016 - April 2016
cGMP Remediation work (response to a 483) with an international pharmaceutical client
Eastern Europe
- Provided GMP expertise as a member of the Aseptic Practices and Behaviors, and Microbiology Laboratory teams for remediation work in response to a 483 on a project with PAREXEL for an international pharmaceutical client (oral solid dosage manufacturer) in Eastern Europe
- Wrote and assisted in the execution of protocol for microbial testing of water samples
Senior Consultant, QSC
November 2014 - February 2016
Manager of Quality Control for data remediation work with DMPK Bioanalytical team at Vertex Pharmaceuticals
Boston, MA
- Served as Manager of Quality Control for Remediation work on data integrity project with large oral solid dosage manufacturer
- Reviewed client’s bioanalytical data relating as part of the Data Integrity review team
- Performed Data Integrity analysis, with audit trail review and investigation
- Carried out QC review of the following:
- Responses (Deviations [NCR], Note-to-Files, Response-only) written by the Remediation team to 1750 Observations
(Critical, Major, and Minor) made from the review of client's DMPK Bioanalytical data for CSF and Cardio drugs
2) Responses to 750 Observations (Critical, Major, and Minor) made from review of client’s laboratory logbooks as part of official shutdown of client's Laboratory facility
3) Study Binders, Validation Reports, etc., for conformance to GLP guidelines, SOPs, and best practices
4) White position Papers (12) written by QSC for submission to FDA
5) LC/MS data (analysis of chromatography peak data, including system suitability [e.g., OOS] analysis)
- Used Watson,™ Analyst,™ and Nugenesis™ to carry out QC review of bioanalytical data
Independent cGMP Quality Auditor with NSF Health Sciences, a Division of NSF International
October 2014 - November 2014
Bangalore, India
- SOP (review, editing, and writing), and Batch Record review/certification to Agila Specialties (a developer, manufacturer, and marketer of generic sterile injectable products), an India-based company (acquired by Mylan Pharmaceuticals)
- Wrote and assisted in the execution of protocol for TOC testing of water samples
Independent Consultant with The Quantic Group, Ltd.
March 2014 - August 2014
Syracuse, NY
- Functioned as SME to successfully gain FDA approval and marketing of two immunotherapy cancer small molecules (Nivoluzumab and Elotuzumab) as follows:
- Provided bioanalytical, ADME, and DMPK expertise and assistance with the writing and filing of BLAs
- Served as SME in the review of bioanalytical, ADME, DMPK, and drug delivery data in support of reference standards selection for Nivoluzumab and Elotuzumab
- Coordinated and assisted in the development of Small Molecules Reference Standards program
GMP Quality Auditor: Independent Consultant with PAREXEL International
July 2013 - February 2014
Indore, India
- Performed GMP baseline audits; wrote, reviewed, and edited GMP baseline audit reports as part of the PAREXEL Consent Decree team with a confidential API manufacturer client in India
GMP Quality Auditor: Independent Consultant with PAREXEL International
Bedford, OH
February 2013 - July 2013
- Wrote, edited, and reviewed 51 GMP Quality audit reports as a member of the Consent Decree Inspection Team with pharma client (Ben Venue Labs)
Independent Consultant: cGMP Recruiters, Inc.
September 2012 - January 2013
Greenville, SC
- Performed GMP quality audits for PAI (Pharmaceutical Associates Inc. (contract-manufacturer of generic pharmaceutical liquids.
- Audited client’s commercial product supply chain
- Scheduled and conducted internal quality audits of all departments
- Conducted follow-up audits as necessary to address non-compliance issues
- Prepared audit reports and initiated CAPAs
Independent Consultant: The Quantic Group, Ltd.
June 2011 - September 2012
Allston, MA
- Served as Analytical Method Development, and Validation SME on Consent Decree project for Sanofi Genzyme
- Carried out investigations with Root Cause Analysis of over 1000 Major and several Critical deviations (NCR), and wrote investigation reports
- Provided mentoring for Downstream Manufacturing Purification team
- Supported method development and validation efforts as SME for the ALCM (Analytical Life Cycle Management) team
- Performed assessment of over fifty methods related to the manufacturing of Cerezyme and Fabrazyme
- Wrote and edited Validation Master Plan in support of ALCM team efforts
- Performed assessment of CAPA effectiveness (including legacy CAPAs) for Downstream Manufacturing team
- Performed Gap analysis in support of Specification development efforts
RESEARCH & DEVELOPMENT EXPERIENCE:
Head of Clinical Research & Development, Cambridge Biomedical
June 2010 - June 2011
Cambridge, MA
- Managed all scientific and technical operations within CRO environment, with six direct reports
- Ensured site readiness in accordance with BIMO requirements
- Validated bioassay for establishing clinical trial exclusion/inclusion (based on genetic variants) for patients with Fabry Disease, for external biotech client (confidential)
- Oversaw and conducted internal and external Technology Transfer activities
- Managed clinical research operations for assay development and validation activities working with pharmaceutical clients
- Directed 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
- Directed the day-to-day assay development/validation activities of Clinical R&D staff (MDs, PhDs, Research Technicians, Junior Personnel)
- Developed and validated Immunoassays under GLP and FDA guidelines
- Wrote, reviewed (as Management or Technical reviewer) SOPs, Validation Protocols, Validation Reports, and other key technical documents
- Acted as key technical liaison for programs contracted to the company through its Contract Services Business
- Worked with clients in the design and execution of preclinical studies evaluating biodistribution and PK/PD parameters involving biologics (nucleic acids and proteins)
- Performed role as Site Study Director for several key GLP projects in support of Contract Research efforts
- Supported Sales/Marketing team functioning as Scientific Technology Leader in support of new business opportunities
- Prepared abstracts and presentations; Attended and presented at scientific meetings
Antigen Discovery Division Head/ Team Leader: Medical Diagnostic Laboratories, LLC
November 2007 - May 2010
Hamilton, NJ
- Designed, directed, and managed all projects within the Antigen Discovery team
- Supported Technology Transfer activities between Antigen Discovery team and Clinical Diagnostic Laboratory / commercial partners
- Managed Antigen Discovery Division budget
- Actively engaged in laboratory research while performing functions and duties as Division Head
- Managed team of PhDs, 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
- Acted as a key technical liaison for programs contracted to the company through its Contract Services Business
- Worked with Intellectual Property (IP) attorneys in the drafting and submission of 21 (domestic and international) 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
Research Immunologist, Immunology Division, Medical Diagnostic Laboratories, LLC
February 2006 - May 2007
Hamilton, NJ
- Carried out research relating to the 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
Field Applications Scientist, Ingenuity Systems
November 2005 - January 2006
Northeast Territory
- 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
Sales Representative, USB Corporation
November 2004 - November 2005
Mid-Atlantic Territory
- 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%
Genomics Consultant, Napro Biotherapeutics (Genomics Division)
June 2003 - October 2004
Newark, DE
- Provided scientific expertise on Napro’s proprietary genomics technology to prospective buyers following company downsizing prior to shut-down of operations at the Delaware site
Senior Scientist: Napro Biotherapeutics (CRO), (Genomics Division)
August 2002 - March 2003
Newark, DE
- 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 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
- Successfully planned and carried out cloning projects for a large-scale Biotechnology company, which resulted in the rewarding of a major contract (valued in excess of $1 million dollars)
Field Applications Specialist (Imaging Systems, Proteomics), Amersham Biosciences (now part of GE Healthcare)
June 2000 - July 2002
Mid-Atlantic and Southeast Territories (Imaging Systems)
North America Territory (Proteomics)
- 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 Amersham applications laboratory
- 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
- Provided Applications support for the Mid-Atlantic and Southeast regions of the US
- Successfully completed Consultative Selling Skills Training course
Research Assistant Professor/Principal Investigator: Dept. of Surgical Oncology, West Virginia University School of Medicine: Robert C. Byrd HSC
February 1998 - April 2000
Morgantown, WV
- Independent Investigator responsible for designing, planning, and management of laboratory research projects, data analysis/publication, and grant-writing
- Supervised and managed the work of laboratory personnel
- Successfully designed and carried out research project to identify and characterize differentially expressed genes in human bronchial epithelial cells transformed with 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 evidence of the mitochondrion as a target of tobacco-specific carcinogens
- Successfully designed and carried out research projects to elucidate differential gene expression in human lung cells Normal vs. transformed) treated with the chemotherapeutic agent, Paclitaxel (Taxol).
- Awarded grant from The American Cancer Society entitled, "Differential Display PCR Cloning of Taxol-Responsive Genes in Immortalized, Carcinogen-Transformed Human Lung Cells."
- Provided mentorship and acted as international sponsor for Preeclampsia research project. In this capacity, we sought to apply Differential Display PCR to uncover cDNAs whose expression profile is altered in tissues obtained from patients with preeclampsia. The results of our work were presented at two international conferences and meetings
- Collaborated on cell-signaling project with colleagues at the Mary Babb Randolph Cancer Center
Senior Research Associate: Laboratory of Experimental Pathology, West Virginia University School of Medicine: Robert C. Byrd HSC
October 1995 - December 1998
Morgantown, WV
- 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
Research Training Fellow: Laboratory of Cell Biology, National Institutes of Health (National Heart, Lung, and Blood Institute)
September 1993 - September 1995
Bethesda, MD
- Carried out Postdoctoral work in the laboratory of Dr. E.D. Korn, (member of the National Academy of Sciences)
- Successfully 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 over 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
FELLOWSHIPS AND AWARDS:
Merck Chemical Company Pre-Doctoral Fellowship
Hebrew Technical Scholarship
City University of NY Training Fellowship
NIH Intramural Research Training Award
Awarded grant from American Cancer Society for work entitled, “Differential Display PCR Cloning of Taxol-Responsive Genes in Immortalized, Carcinogen-Transformed Human Lung Cells."
PUBLICATIONS (selected list from 13 total):
- Brzeska, H., Szczepaowska, J., Hoey, J.G., and Korn, E.D. (1996). The catalytic domain of Acanthamoeba myosin I heavy chain kinase II. Expression of active catalytic domain and sequence homology to PAK kinases. J. Biol. Chem. 271:
- Hoey, J.G., Garrett, S.H., Sens, M.A., Todd, J.H., and Sens, D.A. (1997). Expression of Mt-3 mRNA in human kidney, proximal tubule cell cultures, and renal cell carcinoma. Toxicology Letters 92:149-160.
- Hoey, J.G., Sammy, J., and Flynn, D.C. (2000). Chimeric constructs containing the SH4/Unique domains of cYes can restrict the ability of Src (527F) to upregulate heme oxygenase-1 expression efficiently. Signal. Oct 12(9-10):691-701.
- Wagner L., Hoey, J.G., Erdely A., Boegehold M.A., and Baylis C. (2001). The nitric oxide pathway is amplified in venular vs. arteriolar cultured rat mesenteric endothelial cells. Microvasc Res. Nov; 62(3):401-9.
- McCool, T., Hoey, J.G., Montileone, F., Goldenberg, H.B., Mordechai, E., and Adelson, M.E. (2008). Discovery and analysis of Bartonella henselae antigens for use in clinical serological assays. Diagn Microbiol Infect Dis. Jan:60(1):17-23.
- Goldenberg, H.B., Valois-Cruz, F., Mordechai, E. Adelson, M.E., and Hoey, J.G. (2008) Identification of Babesia microti antigens and development of diagnostic IgG and IgM ELISA’s for Babesiosis. Clinical and Vaccine Immunology.
- Hoey, J.G., Valois-Cruz, F., Goldenberg, H.B., Huang, L., Vozkoboynik, Y., Pfiffner, J., Mordechai, E., and Adelson, M.E. (2009). Development of an IgM capture-based ELISA for detection of acute infection with Bartonella henselae. Clinical and Vaccine Immunology, 16(2): 282–284.
PATENTS (selected list from 21 total):
- John G Hoey, Lisa P Huang, Martin E Adelson, Eli Mordechai: Detection kit containing a novel recombinant 15-kDA polypeptide useful for detecting human infection with. Medical Diagnostic Laboratories. Nov 12, 2013: US8580271 (B2)
- Denise Dimitrov, John G Hoey: translocated substrate-1 (ATS-1) and sero-detection of. Medical Diagnostic Laboratories. Jun 4 2013: US8455211 (B2)
- John G Hoey, Hannah Venit, Martin E Adelson, Eli Mordechai, Fernando Valois Cruz: genomic clones containing novel antigens useful in the diagnosis of babesiosis. Medical Diagnostic Laboratories. Mar 5 2013: US8388981 (B2)
- John G Hoey, Denise P Dimitrov, Lisa B Huang, Martin E Adelson, Eli Mordechai: Protein fragments of virB10 and sero-detection of. Medical Diagnostic Laboratories. Mar 5 2013: US8389678 (B2)
- John G Hoey, Denise P Dimitrov, Lisa P Huang, Martin E Adelson, Eli Mordechai: Type IV secretion system proteins in sero-detection of. Medical Diagnostic Laboratories. Dec 25 2012: US8338190 (B2)
MILITARY SERVICE:
United States Navy (1980-1984)
Rate: Hospital Corpsman (with Field Medical Training/Surface Warfare Specialist rating (HM2/SW)
Final Rank Attained (2nd Class Petty Officer (E-5)