Qualified Microbiologist with background in GMP, GLP, FDA, AOAC and quality assurance. I have worked in the personal care industry as a R&D microbiologist with a heavy emphasis on manufacturing sites.
Overview
27
27
years of professional experience
1
1
Certification
Work History
Principal Investigator, Microbiology
SGS North America Inc.
02.2024 - Current
Principal Investigator and subject matter expert for microbiological in-vivo and in-vitro studies.
Created procedures for microbiology lab and clinic functions.
Worked cross-functionally to develop standard protocols, recruiting parameters and data analysis.
Participates in training of microbiology and clinical staff in the fundamentals of testing using standardized microbiological methods.
Active participant in ASTM, HCPA and Personal Care Products Council (PCPC) Microbiology Committee.
Manager of Microbiology
SGS-Stephens Inc.
08.2021 - 02.2024
Responsible for the operations of the Microbiology lab.
Created procedures for microbiology lab functions.
Worked cross-functionally to develop standard protocols, recruiting parameters and data analysis.
Responsible for training of direct reports and clinical staff in the fundamentals of testing using standardized microbiological methods.
Principal Investigator and subject matter expert for microbiological in-vivo and in-vitro studies.
Active participant in ASTM, HCPA and Personal Care Products Council (PCPC) Microbiology Committee.
Manager of Analytical Chemistry and Microbiology
Henkel
05.2020 - 07.2021
Supervision, coaching and development of 1 Principal Scientist in Analytical and 1 in Scientist in Microbiology.
Performs the duties of Manager as well as actively working in the Microbiology Laboratory, by providing guidance / teaching to the 1 Microbiologist, performing day to day lab duties, including performance of testing, data analysis, reporting of results and act as the subject matter expert for Microbiology in North America.
Delivered feedback to decision-makers regarding employee performance and training needs.
Provide expert guidance to product development and senior leadership around formulations and claims substantiation testing for both EPA and FDA regulated products.
Continued to work on the program for process improvement in Microbiology
Principal Microbiologist- Laundry & Home Care
Henkel
01.2020 - 05.2020
Performed a gap analysis and developed a program for process improvement in Microbiology with future implementation for the Analytical Laboratory. This included a training matrix / proficiency testing program, implementing a review process of formulations and raw materials prior to submission for testing to ensure best use of resources as well as creation of a document management system, written SOP's, Test Methods, and system for traceability of test results.
Provided guidance to manufacturing plants and co-packers around hygienic manufacturing and microbiological requirements.
Responsible for reviewing and providing input on raw materials, in-process materials, and finished goods for microbial susceptibility.
Lead initiative within R&D for creation and implementation of a housekeeping / safety program with routine audits.
Principal Microbiologist – Beauty Care
Henkel
01.2018 - 12.2019
Responsible for supervision of day to day operation of microbiology laboratory as well as provide expert guidance to senior leadership.
Principal Investigator and subject matter expert for Human Subject Clinical Studies in support of microbiological claims substantiation for submission to regulatory bodies.
Responsible for maintaining cGMP compliance within Henkel Consumer Goods Microbiology department.
Perform microbiological testing per internal and standardized methods (USP, Pharmacopeia Europe, ISO) for preservative efficacy, microbial limits, suitability testing.
Lead claim substantiation testing of existing product forms for new claims or for personal care products under development. Testing performed included Time Kill Kinetics, Healthcare Personnel Handwash.
Provided microbiological training, hygienic manufacturing support and cGMP guidance to R&D and manufacturing sites in the Americas.
Worked with corporate and manufacturing site personnel for resolution of out of specification situations and to implement corrective and preventative action if necessary.
Participated on cross functional teams for manufacturing site changes, new product introductions or changes to processes.
Lead Microbiology Auditor of Quality System audits for new and existing manufacturing facilities as well as raw material manufacturers (company owned and contract manufacturers).
Lead team to review and implement best practice test methods for Henkel global to develop one set of standards for all manufacturing and R&D which comply with all regional regulations.
Performed microbial identification utilizing 16SrDNA sequencing of standard laboratory organisms as well as manufacturing isolates.
Active participant in ASTM and Personal Care Products Council (PCPC) Microbiology Committee.
Principal Scientist – Microbiology Beauty and Laundry & Home Care
Henkel
12.2011 - 12.2017
Supported all business units of Henkel Consumer Goods (Beauty Care, Home Care and Laundry). Included both FDA and EPA regulated products.
Responsible for supervision of day to day operation of microbiology laboratory as well as provide expert guidance to senior leadership.
Responsible for maintaining cGXP compliance within Henkel Consumer Goods Microbiology department as well as ISO certifications per ISO 9001, 14001 and OHSAS 18001.
Perform microbiological testing per internal and standardized methods (USP, Pharm EU, ISO) for preservative efficacy, microbial limits, suitability testing.
Lead claim substantiation testing of existing product forms for new claims or for personal care products under development. Testing performed included Time Kill Kinetics, Healthcare Personnel Handwash.
Provided microbiological training, hygienic manufacturing support and cGMP guidance to R&D and manufacturing sites in the Americas.
Worked with corporate and manufacturing site personnel for resolution of out of specification situations and to implement corrective and preventative action if necessary.
Participated on cross functional teams for manufacturing site changes, new product introductions or changes to processes.
Lead Microbiology Auditor of Quality System audits for new and existing manufacturing facilities as well as raw material manufacturers (company owned and contract manufacturers).
Lead team to review and implement best practice test methods for Henkel global to develop one set of standards for all manufacturing and R&D which comply with all regional regulations.
Performed microbial identification utilizing 16SrDNA sequencing of standard laboratory organisms as well as manufacturing isolates.
Lead ASTM working groups and authored antimicrobial claim substantiation methods for Time Kill as well as Health Care Personnel Handwash.
Participated a job rotation in Dusseldorf, Germany at Henkel Headquarters, learning EN test methods for microbiological products as well as learning microbiological studies on axillary and oral microflora.
Acted as site archivist for all regulated documentation.
Senior Scientist – Microbiology Beauty and Laundry & Home Care
Henkel
09.2006 - 12.2011
Responsible for maintaining cGMP, GLP compliance within the Henkel Microbiology department.
Provided guidance to manufacturing plants and co-packers.
Developed standard operating procedures and test methods.
Performed microbiological testing per internal and standardized methods (USP, Pharm EU, ISO) for preservative efficacy, microbial limits, suitability testing for Beauty Care and Home Care Products.
Performed claim substantiation testing of existing product forms for new claims or for personal care products under development.
Testing performed included Time Kill Kinetics, Healthcare Personnel Handwash.
Provide microbiological training, hygienic manufacturing support and cGMP guidance to R&D and manufacturing sites in North America.
Quality Analyst
Henkel
02.2005 - 09.2006
Conducted quality audits of manufacturing plants, co-packers, and warehouse facilities to assure compliance to corporate quality policies, procedures, and manufacturing directives.
Created, edited, and updated quality assurance program elements including quality assurance sampling and testing plans, and quality standards.
Conducted competitive product quality surveys and analyzes.
Scheduled and conducted site visits, set audit priorities.
Interpreted quality results and provided recommendations.
Reviewed and acted upon co-packer monthly reports.
Developed new quality assurance programs designed to solve specific problems.
Scientist
Henkel / The Dial Corporation
02.1999 - 02.2005
Performed microbiological testing of cosmetic and OTC Drugs for both claims and QC analysis.
In charge of daily lab tasks: Media preparation and quality control, temperature monitoring, reading of test results and reporting data.
Assisted in maintaining cGMP compliance within the Dial Microbiology department.
Assisted with development of standard operating procedures and test methods.
Provided guidance and conducted quality audits of manufacturing plants and co-packers to assure compliance to federal regulations, corporate quality policies and procedures.
Assisted the Innovation group with the development of novel antibacterial formulations and product forms.
Education
Bachelor of Science - Microbiology
Arizona State University
Certificate - Cosmetic Science
University of Cincinnati
Masters - Pharmaceutical Sciences, emphasis on Cosmetic Science
University of Cincinnati
Skills
Collaborative research
Scientific communication
Interdisciplinary knowledge
Research design
Certification
American Society for Quality- Certified Quality Auditor, 2005, 2008
American Society for Quality- Certified Quality Technician, 2005
Languages
English
Native or Bilingual
Publications
The Effect of Antimicrobial Hand Washes on Methicillin Resistant Staphylococcus aureus. ASM 108th General Meeting, May 2008, G.E. Fischler, M.H. Duran, J.L. Fuls, N.D. Rodgers, A. Waggoner, G. Cole, A. Petrangeli
A New Method For Assessing the Transfer of Pathogenic Bacteria From The Hands to Food or Other Items Following Handwashing, ASM 107th General Meeting, May 2007, G.E. Fischler, J.M. Howard, M.H. Duran, J.L. Fuls, N.D. Rodgers, A. Waggoner, M. Patel, P.L. Weidner
A Novel and Alternative Method for Contaminating the Hands using the ASTM E1174 Health Care Personnel Handwash Method. ASM 107th General Meeting, May 2007. J. Howard; M. Patel; P. Weidner; M. Duran; A. Waggoner; N. D. Rodgers; J. L. Fuls; G.E. Fischler
The Hand to Hand Transfer of Bacteria, an Evaluation of Antibacterial Effectiveness Using a Cup Scrub Modification of the ASTM E 1174 Health Care Personnel Hand Wash Method. G.E. Fischler, J.L. Fuls, P.L. Weidner, A.L. Waggoner, J.M. Howard. American Society of Microbiology poster, 2004.
Compositions Having Enhanced Deposition of a Topically Active Compound on a Surface. US Patent No. 6,8641,397 B2
High Efficacy Antibacterial Compositions Having Enhances Esthetic and Skin Care Properties. US Patent No. 6,977,082
Timeline
Principal Investigator, Microbiology
SGS North America Inc.
02.2024 - Current
Manager of Microbiology
SGS-Stephens Inc.
08.2021 - 02.2024
Manager of Analytical Chemistry and Microbiology
Henkel
05.2020 - 07.2021
Principal Microbiologist- Laundry & Home Care
Henkel
01.2020 - 05.2020
Principal Microbiologist – Beauty Care
Henkel
01.2018 - 12.2019
Principal Scientist – Microbiology Beauty and Laundry & Home Care
Henkel
12.2011 - 12.2017
Senior Scientist – Microbiology Beauty and Laundry & Home Care
Henkel
09.2006 - 12.2011
Quality Analyst
Henkel
02.2005 - 09.2006
Scientist
Henkel / The Dial Corporation
02.1999 - 02.2005
Certificate - Cosmetic Science
University of Cincinnati
Masters - Pharmaceutical Sciences, emphasis on Cosmetic Science