Medical Technologist -Microbiology, cGMP Bioanalyst, cGMP QA QC

Neal H. Wright, RMT

* *** **., #***

Wakefield, MA 01880

Tel: 781-***-****

*************@*****.***

Summary

Forty years as Bioanalytical and Quality Control QA QC Specialist for

Biopharmaceutical Contract Research Organizations, Contract Manufacturing

Organizations CRO, CMO and CMC Manufacturing, FDA 21 CFR 11 cGMP/cGLP, U.S.

CLIA, ICH, ISO expertise, Bioanalytical Methods Development and Validation,

Analytical applications development and Instrumentation PM-CAL,

Qualifications IQ, OQ, PQ. API Stability Testing Expertise, Sterility,

HPLC, UPLC, IEC, Chiral LC, FPLC, Mass Spectrometry: MALDI-TOF-MS, ESI-MS,

LC-MS, UV-VIS Scanning Spectrophotometry, Optical Rotation Polarimetry, SDS

PAGE electrophoresis, SPEP immuno-electrophoresis, Northern & Western

immunoblotting, FTIR, Karl Fischer Analysis, Osmometry, Melting Point

Determinations, Accelerated Light Stability Testing, Iso-electric focusing,

HPCE Capillary Electrophoresis, Solubility profiles, Dissolution testing,

Viscosity, Quantitative Gravimetric Analysis, Loss on Drying LOD,

Quantitative Amino Acid Analysis, Edman Protein Sequencing, ELISA, Protein,

Peptide and Oligonucleotide Molecular, Characterization Chemistry, In-Situ

enzymatic digestions, Peptide synthesis chemistry expertise, HPLC &

Chromatographic Purifications, Lyophilization, Microbiology Aseptic

Techniques, Bio-burden Assays, LAL Endotoxin testing, Microbiology Culture,

colony counts, Biochemical ID & MIC's, Particle Counts, Hematology & Cell

counting, Coagulation, Immunohematology, Clinical Biochemistry, Immunology

Serology & Allergy testing, Therapeutic Drug Assay TDA Fluorometric methods

development,

Environmental Health & Safety HAZMAT & Bio-Safety expertise for blood and

tissue based specimen processing. Technical Review & Technical Writing of

QMS documents SOP's, QMS documents, Certificates of Analysis, Certificates

of Origin (BSE-TSE), MSDS, Environmental Health & Safety documents.

Bioanalytical and Bio-Manufacturing systems design, Applications

Development, Medical Device Patent Application experience. Instrumentation

systems expertise, Technical Writing of operators manuals and expertise in

preventative maintenance (PM) and Calibration verification's.

Overlapping Career: 25+ years Quality Assurance/Quality Control in U.S.

CLIA regulated Medical Clinical Diagnostic Laboratory Sciences; Hematology,

Coagulation, Clinical Biochemistry, Clinical Toxicology, Allergy Immunology

Serology, Testing, Immunohematology, Medical Diagnostic Microbiology;

Bacteriology including biochemical identification and MIC's, Mycology,

Instrumentation and Reagents Validations, Quality Control and Proficiency

Testing under U.S. CLIA requirements. Laboratory Management, staff

selection, training and supervision.

Neal H. Wright, RMT

Professional Experience:

STAT-CAPA NHW Consulting Services, Wakefield MA May 2011-present

Founder, Director: Field Services Headquartered in Wakefield MA 01880 USA

Providing QA, QC, cGLP, cGMP,, FDA, Q7A, & ISO,

Remedial QA & CAPA consulting services including: IQ, OQ PQ Instrumentation

& Equipment qualifications, Regulatory Compliance support, Technical

writing; SOP's, Quality Manuals, QMS Systems, Batch Records, Approved

Suppliers audits, Quality Systems Internal & External audits, Environment

Health and Safety EHS OSHA / EPA Audits, Safety Training, SOP & QMS

Technical Writing, Staff Training & Development Documentation, Analytical

Applications Development, Analytical Methods Development & Validation, and

Support for Bio-Analytical Bio-Processing, Contract Manufacturing CMO,

Contract Research CRO consulting.

Faulkner Medical Laboratories, Inc. Malden MA May 2012-Sept. 2014

Part Time Medical Technologist: Hematology-

Coagulation, Clinical Chemistry, QA QC.

ChemGenes Corporation, Wilmington MA Dec. 2008-May 2011

Director of Quality; Quality Assurance

(presently under non disclosure/confidentiality and non-competition

agreements)

Contract pharmaceutical phosphoramidite intermediates manufacturer under

GMP quality agreements. Responsibilities: Auditors hosting and

communications, Analytical QC lab instrumentation IQ OQ PQ Qualifications,

New SOP writing and revisions, documented SOP staff training, Environmental

Health & Safety, and GMP regulatory compliances under quality agreements.

QMS documentations of CMC manufacturing deviations, OOS and CAPA, Internal

audits, Supplier and supply chain qualifications, review and or writing of

of C of A and C of O (BSE-TSE) and MSDS documents, External Audit review-

and selection oversight for Contract Research Organization (CRO) outsource

Analytical facilities and calibration services providers. Solvent

purifications systems design, QMS of product manufacturing, packaging and

labeling processes.

Regeneron Pharmaceuticals, Inc. Farmington NY Sept. 2009-May 2010

NHW Consulting*, Professional Consultant: On site and primarily

telecommuting Analytical Method Validation project.

Omega PharmServices, Inc., Milford, MA Contracted Aug. 2006 - May

2007 Consulting Laboratories Director DBA NHW Consulting Services*

Providing, Method Validations for cGMP/cGLP/QA-QC requirements for API and

intermediates. Pharmaceutical Purity, Stability analysis. Data review and

interpretation, Regulatory Reports, SOP Technical Writing, review and

compliance support. Analytical services including: Formulation, Aseptic

Processing, System suitability testing, Utilizing Biochemistry, HPLC, Ion

Exchange Chromatography, Capillary Gel Electrophoresis CGE/HPCE, ESI and LC-

MS Mass Spectrometry, Forced degradation testing, Dissolution, Solubility,

Karl Fisher Moisture Analysis, Product and Clean Room Bio-burden

Microbiology & Endotoxin testing. Actively engaged in high-level Strategic

Business Development functions including Technical Internet Marketing

Expertise, planning and development of collaborative industry business

agreements through relationship building and professional negotiation

communications.

Neal H. Wright, RMT

* NHW Consulting Services, (dba), Wakefield MA 01880 Jan 2006-present

Director, Consultant, Principle

QC Analytical Instrumentation sourcing and installation on-site

professional staff training, Preventative Maintenance (PM) and Calibration,

Instrumentation Qualifications: IQ, OQ, PQ, Applications Development,

Methods Development & Validations.

Analytical Technologies Group, Inc., Groton, CT Jan. 2006- Feb 2011

NHW Consulting*Part time professional

Consultant: Bioscience Technologies Business Development & Instrumentation

Specialist, IQ, PQ, OQ, Validations. IT Web Development projects

Eastman Kodak (non disclosure agreement in effect) Jul- Nov

2008

NHW Consulting*Part time professional Consultant: Pharmaceutical

formulations study

Bio-Boston Contract Laboratories Beverly, MA 2007

Co-Founder, Senior Business Partner: Bioanalytical Contract Service

Laboratories & services CRO, QC Regulatory Compliance, Business Development, Director Bioanalytical Services, Peptide Synthesis, HPLC, AAA, MS, LAL

Endotoxin testing

Amphotech Corporation, Beverly MA & Amphotech LTD, London UK 1995-2006

President CEO, Director: Bioscience Biotechnology Contract Research

laboratories CRO, Reagents manufacturer and subdivisions: Laboratory

Instrumentation supplier and Ultra-Pure Research Grade Biochemicals

Manufacturer, Custom services included cGMP manufacturing, Peptide

Synthesis, HPLC, MS, AAA, Optical Rotation Polarimetry, Stability testing.

Harvard Medical School Dept. Genetics, HHMI Biopolymers Facility, Longwood

Medical School Campus, Boston MA 1993 - 1996 Senior Research Associate:

Custom Peptide Synthesis, Purifications, Analytical Chemistry,

Quantitative Amino Acid Analysis, HPLC, Mass Spectrometry. Including but

not limited to the following acknowledgments: Dr. Roderick MacKinnon:

Crystal Structures of a Complexed and Peptide-Free Membrane

...www.sciencedirect.com/science/article/pii/S0092867400813070

by DA Doyle - 1996 - Cited by 748 - Related articles Jun 28, 1996 - Modular

PDZ domains, found in many cell junction-associated proteins, ...Roderick

MacKinnon1, #, Corresponding author contact information ...

Acknowledgements ... Peptide was synthesized by Neal Wright, Michelle

Obenauer, and Dr. John Rush.

Dr. Howard Green, HMS HHMI

http://www.pnas.org/content/93/25/14580.full.pdf We thank Neal Wright and

Dr. John Rush of the Biopolymers Facility at Harvard Medical School for

their valuable advice and their preparation of all peptides.

Harvard University Microchemistry Facility, Cambridge MA 1986-1991

Faculty of Arts and Sciences Senior Research Associate: Quantitative Amino

Acid Analysis, HPLC, Mass Spectrometry, In-Situ enzymatic protein

digestions for protein sequencing, Protein biochemistry, Peptide Synthesis,

purification and characterizations,

Boston University Medical School Immunology & Infectious Disease Research,

Boston MA

Maxwell Finland Institute: 1985 (grant funded position). Senior Research

Associate

Microbiology, Cell culture, Protein isolation purification, Immuno-

chemistry, lyophilization, electrophoresis, ELISA, Chromatography.

Neal H. Wright, RMT

The above professional experience followed a full time and overlapping part

time Professional

Medical Career of more than 25 years as Medical Technologist, Chief Medical

Technologist & Clinical Laboratories Manager: Certified by U.S. HHS, AAGB,

ISCLT,ASCP, NCA Providing diagnostic Hematology, Coagulation, Hemostasis,

Immunology-Serology, Microbiology, Bacteriology, Biochemistry, &

Therapeutic Drug Monitoring-Toxicology services in major teaching hospital

medical centers (Boston area). Details available upon request.

Education, Continuing Education, Certifications, Affiliations and Awards:

Carnegie Mellon University OLI February 2015 to present: Empirical Research

Methods, Engineering Statistics, Health Information Technology, Probability

and Statistics, Statistical Reasoning, Media programming.

Laboratory Informatics Institute,LIMS University February 2015 to present:

Bioinformatics, Health Informatics Terminology, Ethics and Issues In Public

Health, Epidemiology.

Thomas Edison State College, Trenton NJ

1987-

1989 Applied Science & Technology, CME: Medical Clinical Diagnostics,

Medical Technology

American Society of Clinical Pathologists (ASCP)Recipient of Awards for

Continuing Medical Laboratory Education 1988, 1989

American Society of Clinical Pathologists (ASCP) Tech-Check program 1984-

1988

Boston State College, Boston, MA 1981

B.S. Biological Sciences, Allied Health Clinical laboratory Science

Northeastern University, School of Allied Health & PharmacyBoston, MA 1977

MLA/MLT/c Medical Diagnostic Clinical

Laboratory Sciences. AMA, ASMT, ASCP, CAP, NIH, CDC, USPH accredited

program: Hematology, Coagulation, Serology, Biochemistry, Immunohematology,

Microbiology, Bacteriology, Parasitology, Clinical Diagnostic Microscopy

CERTIFICATIONS, AWARDS AND AFFILIATIONS

Certifications:

. Clinical Laboratory Technologist (CLT-HHS) U.S. Dept. Health & Human

Services

. Registered Medical Technologist (RMT-ISCLT) International Society for

Clinical Laboratory*

. Registered Medical Technologist (RMT AAB) American Association of

Bioanalysts*

. MLT (ASCP) American Society of Clinical Pathologists

. CLT-NCA ASCP National Certification Agency for Medical Laboratory

Personnel (NCA).*

* These entities have more recently become part of American Society of

Clinical Pathologists (ASCP)

Honor & Awards:

. Letter of Commendation St. Jude Children's Research Hospital for

obtaining substantial donations of Oncology Research laboratory

Instrumentation and systems 2005

. Recipient of American Society of Clinical Pathologists Continuing Medical

Lab Science Education Awards 1988,89

.

. Recipient of VA Hospital Medical Center Jamaica Plain MA VAVS Outstanding

Service Award for Microbiology lab services 1977

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