QUALIFICATIONS
- Twenty-five + years experience in analytical/bioanalytical methods development and validation
- Twenty-five + years of technical writing and QA of various documentation for both business and scientific purposes
- Twenty years experience in GxP auditing in both domestic and international areas
- Twenty years experience in investigations and writing deviations in GMP and GLP settings
- Fifteen years experience in commissioning, qualification, and validation of GxP laboratory and manufacturing equipment
- Fifteen years experience in process design, validation, and implementation in business, lab, and manufacturing areas
- Twelve years of project management experience
SUMMARY OF CAPABILITIES
Analytical/Bioanalytical Methods Development and Validation – Developed and validated over 150 various analytical/bioanalytical methods for analysis of small molecules and macromolecules which supported preclinical and clinical studies.
GxP Compliance Auditing – Auditing of animal, laboratory, and manufacturing facilities, systems, processes, and documentation for quality and regulatory compliance (FDA, EMA, ICH, OECD) and quality assurance audits for regulatory submission data (preclinical, clinical, critical phase, vendor)
Project Management – Overall project management including cost estimation, risk analysis, scheduling, resource allocation, defining GxP scope, and sub-contractor management. Developed project plans with client management for approvals. Project budget and cost control management of sub-contractors.
Process Design and Validation – Development of processes using flowcharts to describe current “as-is” processes for business, laboratory, and manufacturing systems; design and validation of updated “to-be” processes to increase efficiency and aid in time and cost savings.
Computer Systems Validation (CSV) and Qualifications in GxP Environments – Development, implementation, and execution of GxP controlled documentation protocols for Installation, Operational, and Performance Qualification and Preventative Maintenance of computer-based laboratory and manufacturing equipment.
Quality Management Systems – Design and implementation of CAPA, change control, and GLP deviation tracking systems. Remediation of quality control and quality assurance departments to implement more efficient techniques and bring the departments up to speed with current industry practices.
Technical Writing – Development and implementation of business, laboratory, and manufacturing documentation including regulatory submissions, Master Validation Plans, metrology training procedures, business development plans, validation/qualification protocols, quality manuals, software training manuals, and SOPs.
Software – SME in Microsoft Office applications, including MS Project and MS Visio. Extensive experience with WordPress
EMPLOYMENT
THISS Consulting Group, LLC 09/2005 – Present
1729 9th Street South
Fargo, ND 58103
(701) 367-3832
Owner / Sr. Consultant
Scientific consulting, GxP auditing, project management, and business development services for companies within the pharmaceutical, biotechnology, vaccine, and medical device industries. Projects have included the following:
- (Company Confidential) – Boston, MA
- Led team in remediation of bioanalytical assays used for acquiring preclinical and clinical data for regulatory submissions
- Led the interim quality assurance team in the review of bioanalytical method validations and study reports
- Drafted new Standard Operating Procedures for use after completion of remediation
- (Company Confidential) – Suffern, NY
- Led the remediation of the customer complaint and change control departments
- Led the process design and validation of new business processes for the QA department
- Created, wrote, and implemented training modules to train employees on the company’s TrackWise system
- (Company Confidential) – Clayton, NC
- Interim Quality Control laboratory director
- Developed updated analytical testing methods
- Performed commissioning, qualification, and validation of new analytical instrumentation
- (Company Confidential) – Lansing, MI
- Project managed two (2) international regulatory submission projects and one (1) domestic submission project concurrently handling all aspects (i.e. laboratory testing, production, packaging, budgets of over $10M, planning & generation of new revenue streams)
- (Company Confidential) – Montreal, QC, Canada
- Project manager for the remediation of the ligand binding department to determine the accuracy and validity of all data generated over a 5-year period
Hematech, Inc. 10/2003 – 10/2004
4401 South Technology Drive
Sioux Falls, SD 57106
(605) 361-6793
Sr. Manager of Product Quality Systems
- Led everyday operations of all GLP quality system activities within a vaccine company (data integrity, aseptic processing operations, safety issues, auditing labs, vendor qualification, etc.) and designed the quality control lab.
- Developed and qualified assays (ELISA, RT-PCR, Size Exclusion Chromatography, Western Blot/SDS-Page, HPLC)
- Business development work with IT companies to form a specialized software database
- Member of the following committees: Software development (Chairman), Quality Systems, Safety, Assay Development, Institutional Review Board, and Regulatory Affairs
Quintiles Consulting 12/2002 – 09/2005
4820 Emperor Blvd
Durham, NC 27703
(919) 998-2000
Senior Consultant
Provided consulting services for companies within the pharmaceutical/biotechnology/medical device areas focusing on GxP compliance and quality systems. Projects have included the following:
- (Company Confidential) – Oakwood, OH
- Developed a new metrology program for the client
- Drafted protocols for the commissioning of new GMP manufacturing equipment
- (Company Confidential) – Turku, Finland
- Led a process characterization team to determine reasons for loss of >60% of a biological diagnostic product at the QC level. When finished, the amount of loss had decreased to 18%, which saved valuable time and money for the client
- (Company Confidential) – Kalamazoo, MI
- Performed commissioning, qualification, and validation activities on instrumentation for use in a GMP facility. Instrumentation included Mastersizer particle sizers, Bran+Lubbe TRACCS systems, Agilent HPLC 1100 systems, Agilent 6890 Gas Chromatography systems, various freezers and refrigerators, FTIR systems, etc.
- Drafted commissioning, qualification, and validation protocols for computer system validations
PRACS Institute, Ltd. 03/1996 – 12/2002
4801 Amber Valley Parkway
Fargo, ND 58104
(701) 277-7227
Analytical Scientist / Methods Development Chemist
- Developed and validated bioanalytical methods (both small molecule and macromolecule) supporting preclinical & clinical studies/trials
- Team Leader of Gas Chromatography group (9 employees) for final 3 ½ years of employment
- Developed and validated analytical methods used for the analysis of various biological and pharmaceutical compounds using HPLC w/ UV, FLD, and ECD detection, LC-MS, LC-MS-MS, GC-MS and Capillary Electrophoresis
- Performed and trained other employees on many analytical techniques including solid-phase extraction, organic synthesis, derivitization reactions, and sample purification techniques
- Wrote analytical procedures, SOP documents, and clinical study research protocols
- Repaired (and in some cases rebuilt) and performed metrology on HPLC, GC-MS and LC-MS-MS systems
- Worked with Clinical Research department on projects involving both clinical and analytical work
- Assisted in the planning and purchasing of equipment and supplies
- Chairman of our Analytical Safety team which deals with all safety issues and concerns within our lab
- Member of the Clinical Research Quality Management team and Analytical Quality Management team
USDA Northern Crops Institute 01/1994 – 03/1996
North Dakota State University
1240 Bolley Drive
Fargo, ND 58108
(701) 231-7736
Research Assistant
Worked on a research grant focused on genetic engineering of sunflowers to establish natural biocontrol against red sunflower seed weevils. Techniques performed included Western, Southern, & Northern blots, gel electrophoresis, SDS-PAGE gels, DNA sequencing, PCR, ELISA, RIA, plasmid purification, cell culture, isotope tracing, spectrophotometry, and fluorometry
EDUCATION
George Mason University; Fairfax, VA 09/2003 – 05/2005
- M.S. in Technology Management – Bioscience focus
University of Mary; Bismarck, ND 01/2002 – 05/2003
- Master’s in Business Administration (MBA)
North Dakota State University; Fargo, ND 09/1987 – 05/1992
- B.S. from the College of Science and Mathematics
- Majored in Microbiology / Minored in Chemistry & Biotechnology
- Completed 12 credits of graduate work toward M.S. in Biochemistry
Olivet Nazarene University; Kankakee, IL 09/1985 – 05/1987
- Completed equivalent of an Associate’s degree (A.S.) in Computer Science
CERTIFICATIONS
University of Cambridge (Fitzwilliam College), Cambridge, UK 06/2004
International residency certificate program focusing on differences in regulatory guidelines, business practices, economics, and culture between America and the European Union specifically in the Biotech, Pharmaceutical, and Medical Device areas; program co-sponsored by George Mason University
FDA-GLP through the Society of Quality Assurance, Charlottesville, VA 04/2004
21 CFR Part 11 certified through Pfizer/Legacy Pharmacia training program, Kalamazoo, MI 05/2003
AFFILIATIONS
Professional: Civil:
American Association of Pharmaceutical Scientists (AAPS) North Dakota State Ambassador
American Association for the Advancement of Science (AAAS) Nicaragua Relief Network (NRN) Missionary
American Chemical Society (ACS)
American Society for Microbiology (ASM)
American Society for Quality (ASQ)
Regulatory Affairs Professionals Society (RAPS)