Alan J. Senzel, Ph.D., **** Audubon Drive, Raleigh, NC 27615

919-***-**** or 919-***-****

ac2hnh@r.postjobfree.com or ac2hnh@r.postjobfree.com

EXECUTIVE SUMMARY

Dr. Alan J. Senzel is a Manager and Consultant with over 35 years of diversified experience in Analytical Chemistry, Pharmaceutical Method Development and Validation, Quality Assurance, and Technical Editing and Writing. He has strong hands-on experience directing Publication Programs for scientific associations and preparing a wide variety of documentation for Pharmaceutical and Agricultural Chemicals Corporations to ensure legal compliance with all government regulatory agencies.

He has led and actively participated in successful efforts to register and reregister many drug and pesticide products under both GMP and GLP regulations. He has the ability to present complicated scientific data clearly and succinctly. He is an organized professional with excellent presentation, analytical, documentation, and interpersonal communication skills.

PROFESSIONAL EXPERIENCE/ACCOMPLISHMENTS

Technical Writer – Seqirus, Holly Springs, North Carolina: 6/17 – 8/17

Prepare, or contribute to preparation of, Standard Operating Procedures and Workflow Instructions for Seqirus maintenance documentation associated with manufacture of influenza vaccine products.

Technical Writer – Argos Therapeutics, Durham, North Carolina: 1/17 – 2/17

Prepare, or contribute to preparation of, regulatory clinical documents, including clinical evaluation reports, for Argos Therapeutics products associated with ongoing clinical trials. Documentation includes Standard Test Methods, Method Qualification Protocols, Method Development Reports, and Standard Operating Procedures.

Consultant, Pharmaceutical Chemistry and Information Technology Applications – GLG Councils, New York, New York: 8/15 – 6/17

Provide consulting services for pharmaceutical companies regarding commissioning of manufacturing plants, method development and validation, clinical evaluation reports, regulatory submissions, and information technology applications, as assignments occur.

Technical Writer/Documentation Specialist – Biogen, Research Triangle Park, North Carolina: 3/15 – 8/15

Provide regulatory documentation support for TrackWise applications, including user requirements, design, and functional specifications; data migration, system project, and test plans; and traceability matrices. Assist with TrackWise administration, Crystal reports, and validation documentation, as required.

Medical Writer – Quintiles/Expression Analysis, Durham, North Carolina: 9/14 – 3/15

Prepare, or contribute to preparation of, straightforward regulatory clinical documents, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices, under guidance of senior staff, in accordance with American Medical Writers Association (AMWA) and European Medical Writers Association (EMWA) standards. Participate in project teams and may lead specific tasks, consulting senior staff as necessary. Document workflow for Next Generation Sequencing operations using Boolean logic diagrams developed from Microsoft Visio and freeware alternative programs.

Senior Technical Writer – Novartis, Holly Springs, North Carolina: 4/14 – 6/14

Adapt and update Holly Springs automation SOPs to correspond with regulatory procedures for Delta V automation equipment at sister vaccines manufacturing plant under construction in Recife, Brazil.

Delta V Automation Consultant – Merck, Durham, North Carolina: 5/13 – 8/13

Update Regulatory Requirements Traceability Matrices to correspond with Regulatory Requirements Specifications for Delta V automation equipment at vaccines manufacturing plant.

Technical Writer – HGS/GSK, Rockville, Maryland: 10/12 – 3/13

Prepare supporting regulatory documentation associated with transition of IT Application Services from Human Genome Sciences (HGS) to GSK. Effort required familiarity with MEDLINE and CANCERLIT databases.

Technical Writer – Becton Dickinson Diagnostics, Mebane, North Carolina: 4/12– 9/12

Prepare and update service manuals for field service engineers and technical service engineers to use in maintaining and repairing automated robotic instruments designed to prepare and analyze patient cytology specimens (principally pap smears) associated with women’s health testing.

Senior Compliance Associate – Hospira, Rocky Mount, North Carolina: 1/12– 3/12

Prepare regulatory investigation reports in the Hospira Trackwise system to identify root cause and corrective action/preventive action (CAPA) for manufacturing and laboratory analysis aberrations associated with manufacture of injectable and intravenous generic drug products.

Technical Writer – LensAR, Orlando, Florida: 8/11– 11/11

Prepare user guide to elucidate graphical user interface (GUI) for equipment designed to aid ophthalmologists in performing laser-assisted cataract surgery.

Technical Author – GSK, Research Triangle Park, North Carolina: 5/10 – 10/10

Prepare supporting regulatory documentation associated with user interface modifications for two key drug synthesis software projects (using Agile technology team approach), CRO Request Approval Workflow (CRAW) and Electronic Laboratory Notebook (eLNB).

Technical Editor – Telecommute Pros, Phoenix, Arizona and ELSS, Tsukuba, Ibaraki, Japan: 12/08 – 5/10

Edit English-language research manuscripts in the fields of biology, chemistry, engineering, mathematics, medicine, and physics authored by professors and researchers from China, Korea, Germany, Japan, and Taiwan for publication in American and British scientific journals.

Technical Consultant – GSK, Research Triangle Park, North Carolina: 6/07 – 12/08

Prepare all documentation associated with user interface for two key drug discovery software projects (using Agile technology team approach), Operational Reporting and Metrics (OR&M) and Encoded Library Technology (ELT).

Technical Consultant – Patterson, Dilthey, Wilmington, North Carolina: 3/06 - 10/06

Provide scientific expertise to law firm defending contractors in a case involving alleged harmful exposure via HVAC system to toxic compounds affecting residents of a beach condominium. Case was settled to my client’s satisfaction out of court.

Quality Assurance Associate – ENTHALPY ANALYTICAL, INC., Durham, North Carolina: 1/06 – 3/06

Review and audit analytical data packages (LC-MS) for testing of animal tissues (including rat brain and blood) dosed with developmental pharmaceutical products.

Delta V Validation Engineer – OXFORD GLOBAL RESOURCES, INC., Cordis Johnson & Johnson Site, Miami Lakes, Florida: 11/05 - 01/06

Prepared Delta V regulatory validation protocols and execution reports for testing of cardiac medical devices including hydraulic burst leak tester, linear and lateral stiffness tester, and syringe tester.

Contract Editor – ENVIRONMENTAL HEALTH PERSPECTIVES, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina: 06/05 - 11/05

Edited toxicogenomics monographs for publication in ENVIRONMENTAL HEALTH PERSPECTIVES, a monthly journal published by the National Institute of Environmental Health Sciences.

Documentation Development Specialist – ROVISYS, INC., Wyeth Site, Sanford, North Carolina: 12/04 - 05/05

Prepared DeltaV automation controls documentation for regulatory commissioning of 13-valent pneumonia vaccine manufacturing plant.

Senior Technical Writer/Scientist – CARDINAL HEALTH, Morrisville, North Carolina: 06/02 - 11/04

Prepared method development and method validation regulatory reports for drug development studies sponsored by major pharmaceutical companies, including Astra Zeneca, Bausch & Lomb, Boehringer Ingelheim, Eon Pharmaceuticals, Glaxo Smith Kline, Pfizer, Schering-Plough, Skye Pharma, and West Pharmaceuticals, among others.

Integrated raw data from gas chromatography, high performance liquid chromatography, and mass spectrometry experiments into templates that had to be continually refined to meet customer needs as required.

Prepared Requests for Proposals (RFPs) to solicit new business.

Publications Manager – INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY (IUPAC), Research Triangle Park, North Carolina: 02/99 - 05/02

Managed editing, production, and publication of a monthly research journal and a bimonthly scientific newsmagazine.

Directed technical liaison from headquarters office for 25 international chemistry conferences that IUPAC sponsored each year.

Supervised editing, production, and publication of 35 issues of Pure and Applied Chemistry and 18 issues of Chemistry International (winner of an Excellence Award from the Society for Technical Communication).

Successfully administered 75 international chemistry conferences.

Directed additional IUPAC business, including reprint orders, permissions, publications inventory, and web-based correspondence.

Supervised 3-5 employees.

Consultant, Pharmaceutical Documentation and Validation – ALAN J. SENZEL, Ph.D., Raleigh, North Carolina: 06/96 - 02/99

Prepared software documentation and test plans for a biotech instrument manufacturer (Tecan U.S., RTP, NC). This project included documenting and testing the graphical user interface (GUI) for Tecan’s Genesis series of automated pipetting instruments.

Developed 60 SOPs for a plasma testing laboratory (Bayer Pharmaceuticals PCR Lab, Raleigh, NC)

Prepared 50 SOPs for an analytical testing laboratory (Enthalpy, Inc., RTP, NC)

Created 35 GMP validation documents (IQ, OQ, PQ) for temperature and humidity stability chambers for a pharmaceutical company (Glaxo Wellcome, RTP, NC).

Prepared Requests for Proposals (RFPs) to solicit new business.

Analytical Contract Laboratory Manager – ENTROPY, INC., Raleigh, North Carolina: 05/95 - 07/96

Led team that provided complete analytical support services for air emissions tests conducted in field.

Duties included stocking mobile testing vehicles, custody of samples, selection of and shipment to analytical laboratories for testing, and interpretation of analytical results.

Team successfully completed approximately 500 air emissions tests in continental United States and Puerto Rico.

Prepared Requests for Proposals (RFPs) to solicit new business.

Supervised 3-5 employees.

Consultant, Agricultural Chemical Field Crop Trial Documentation and Data Review – ALAN J. SENZEL, Ph.D., Raleigh, North Carolina: 05/93 - 05/95

Reviewed analytical field crop data from residue chemistry studies and prepared final regulatory reports for registration and reregistration of fungicide, herbicide, and insecticide products for Ciba Plant Protection (Greensboro, NC), American Agricultural Research, Inc. (Cary, NC), Stewart Pesticide Registration Associates, Inc. (Columbia, MO), and the Spray Drift Task Force (Cockeysville, MD) under GLP regulations.

Prepared Requests for Proposals (RFPs) to solicit new business.

Project Scientist – CIBA-GEIGY CORPORATION, Greensboro, North Carolina: 07/88 - 05/93

Managed a group that prepared samples from residue chemistry field crop trials under GLP regulations.

Provided regulatory documentation in support of registration and reregistration of agricultural chemicals under GLP regulations.

Administered all archival information for residue chemistry and metabolism departments in biochemistry division under GLP regulations.

Successfully supported scientific efforts associated with dozens of registrations that involved hundreds of field crop trials under GLP regulations.

Supervised 5-8 employees.

Consultant, Regulatory and Quality Assurance Issues – ALAN J. SENZEL, Ph.D., Raleigh, North Carolina: 05/84 - 07/88

Developed air emissions standards, waste analysis plan guidance manuals, regulatory impact analysis for 200 hazardous chemicals, and exposure assessment guidelines.

Clients included Research Triangle Institute (RTP, NC), Technical Resources, Inc. (Rockville, MD), American Petroleum Institute (Washington, DC), Becton Dickinson, Inc. (RTP, NC), Integrated Laboratory Systems (Durham, NC), and Environmental Resources Management (Exton, PA).

Prepared Requests for Proposals (RFPs) to solicit new business.

Senior Chemist – DEL GREEN ASSOCIATES, INC., Foster City, California: 05/81 - 05/84

Provided technical support and liaison for EPA's Stationary Source Compliance Division to contractor who developed modifications and enforcement of visible emissions methodology.

Continually updated documentation to ensure that enforceable visible emissions methodology was available to EPA's Stationary Source Compliance Division.

Prepared Requests for Proposals (RFPs) to solicit new business.

Consultant, Preventive Maintenance Documentation for Electronic Manufacturing Equipment – ALAN J. SENZEL, Ph.D., Raleigh, North Carolina: 12/78 - 05/84

Prepared more than 100 operation, maintenance, and troubleshooting SOPs for a capacitor manufacturing plant (Corning Glass Works, Raleigh, NC)

Methods Editor – AOAC INTERNATIONAL, Washington, DC: 01/74 - 12/78

Managed development, validation, editing, publication, and continual updating of regulatory laboratory methods for analysis of foods, drugs, pesticides, cosmetics, fertilizers, feeds, disinfectants, hazardous substances, and other materials related to agriculture and public health.

Directed publication of compendia, supplements, and monographs used in U.S. and international regulatory laboratories.

Supervised 2-4 employees.

Associate Editor – ANALYTICAL CHEMISTRY, American Chemical Society, Washington, DC: 06/70 – 01/74

Reviewed and edited feature articles, technical manuscripts, and books on analytical chemistry.

Also authored column on instrumentation every month.

Participated in publication of about 50 issues of journal containing thousands of scientific manuscripts, as well as assembly and production of numerous review compilations, books, and monographs on analytical chemistry.

Authored column on instrumentation every month.

EDUCATIONAL / TECHNICAL BACKGROUND

Ph.D., Analytical Chemistry, UCLA, Los Angeles, California, 1970

M.S., Analytical Chemistry, UCLA, Los Angeles, California, 1969

B.S., Chemistry (Summa cum Laude), CSULB, Long Beach, California, 1967

CERTIFICATIONS

Certified Junior College Chemistry Teacher, California State Junior College System, 1969

ACHIEVEMENTS

Recipient of Society for Technical Communication Excellence Award for Chemistry International (IUPAC), 2002

Successfully completed FIFRA 88 Registration for all Ciba Plant Protection active ingredients, 1993

Recipient of Society for Technical Communication Achievement Award for Safety in the Laboratory (Becton Dickinson), 1984

Recipient of FDA Commendation Award for Manual of Cosmetic Analysis, 1978

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