Gayle F. Shaw
Dunedin
Summary
Biological scientist with 30+ years background in diverse research projects spanning genetics, ecology, and biology. Skilled in data analysis, laboratory techniques, and scientific writing. Demonstrated ability to lead teams in previous roles. Committed to advancing scientific understanding for the future.
Proficient in experimental design, data analysis, and interpretation across various scientific disciplines.
Proven ability to manage laboratory operations and lead teams in conducting complex research projects. Strengths include data analysis, problem-solving, hypothesis testing, and report writing.
Overview
29
29
years of professional experience
2
2
years of post-secondary education
Work History
Sterility Assurance Scientist
Integra Life Sciences
12.2023 - Current
- Support for EUMDR projects-Sterilization remediation (EO-ISO 11135, Gamma-ISO 11137, Steam- ISO 17664)
- EUMDR Gap Assessment for current standards and recertification of current products
- Feasibility studies for EO Cycle changes or other changes (Biological Indicators etc).
- Engineering studies for Comparative Resistance and Bioburden Resistance
- Write and Execute protocol and report
- Collaborate with manufacturing for products
- Collaborate with outsourced lab for study setup and completion.
- Validation of current cycles for addition of nitrogen washes, additional pallets, Low EO concentrations.
- Write and execute protocol and report
- Collaborate with manufacturing for products
- Collaborate with sterilization facility for sterilization validation.
- Collaborate with outsourced lab for completion of testing
- Technical File Product Family remediation
- Review and update to current validation and studies for the sterilization section
- Knowledge of Applicable ASTM, ISO, FDA and EN regulatory Standards
Sterilization Specialist- Microbiologist
Integer Holdings
Palm Harbor
07.2023 - 12.2023
- Support Microbiology Lab as Microbiology SME
- SOP revisions for corporate changes to documents so that all sites are aligned.
- Bioburden, BET, Environmental Monitoring Testing
- Trending and Investigation reports
- Documentation review of EO PPQ, MPQ for in-house and vendor, product adoptions, EO Residuals
- Knowledge and use of Applicable ASTM, AAMI, ISO, FDA and EN regulatory Standards
- Palm Harbor, FL
Senior Microbiologist
Ion Labs Inc.
Largo
05.2021 - 08.2023
- Senior Microbiology Lead
- Validation with current Bioburden Method for historical and new products
- Review and Revise documents to current standard and practices.
- Ensure that incoming lots are tested and released as soon as possible, this includes any stability testing.
- Environmental Monitoring
- Knowledge and use of Applicable ASTM, AAMI, ISO, FDA and EN regulatory Standards
- Regulatory Audit experience
- Largo, FL
Remote Microbiology Consultant
ProPharma Consultant
06.2022 - 11.2022
- Writing and reviewing current SOPS for new microbiology department at an aseptic pharmaceutical.
- Media growth promotion Testing
- Bioburden and BET testing
- Environmental Monitoring Testing
- Aseptic Fill Testing
- Gowning
- Reviewing documentation and compiling report for Investigations for out of spec testing.
- Creation of presentation for general microbiological and aseptic training for manufacturing plant.
- Knowledge and use of Applicable ASTM, AAMI, ISO, FDA and EN regulatory Standards.
- Regulatory Audit experience
Product Specialist/Sterilization Lead
TUV SUD
Peabody
01.2020 - 12.2020
- Performed audits of EO(11135) Gamma Irradiation (11137) sterilization of medical devices for authorizing agency.
- Obtained technical files from customer
- Reviewed data to ensure compliance with current EUMDR standards
- Written reports for this review.
- Work with customers to identify gaps with them and what is needed to ensure compliance.
- Peabody, MA
Sterilization Specialist- Microbiologist
Oscor Inc
Palm Harbor
04.2017 - 01.2020
- Start Microbiology Lab in-house (Bioburden, BET, Water, and EM Testing)
- ETO PPQ, MPQ for in-house and vendor, Adoption of products, ETO Residuals
- Validation and calibration of instruments required for all testing.
- Knowledge and use of Applicable ASTM, AAMI, ISO, FDA and EN regulatory Standards
- Regulatory Audit experience
- Palm Harbor, FL
Medical Technologist II
HCA ST Petersburg General
St Petersburg
03.2016 - 04.2017
- St Petersburg, FL
Regional Manager of Manufacturing and Lab
United Blood Service
Reno
05.2010 - 03.2016
- Reno, NV
Laboratory Manager
Cascade Reginal Blood Service
Tacoma
09.2009 - 05.2010
- Tacoma, WA
Laboratory Manager
Cryo-Cell Inc
Oldsmar
07.2005 - 09.2009
- Oldsmar, FL
Quality Engineer Microbiologist
Cryo-Life Inc
Kennesaw
06.2003 - 07.2005
- Kennesaw, GA
Quality Microbiology Engineer
Bausch and Lomb
Clearwater
06.2001 - 06.2003
- Clearwater, FL
Microbiology Supervisor
Genzyme
Framingham
06.1997 - 06.2001
- Framingham, MA
Education
Master of Arts - Elementary Education
University of Phoenix
Tempe, AZ 05.2010 - 04.2012
Master Business Administration -
University of Phoenix
Bachelor of Science - Biology/Chemistry
Fitchburg State College
Skills
- Strong scientific background in Biology and other sciences
- Knowledge of international standards for microbiological and sterilization
- Safety processes and procedures
- Knowledge and use of applicable standards
- Proficient in microbiological laboratory methodologies and validations
- Problem solving
- Analytical thinking
- Teamwork and collaboration with cross-functional teams
- Self-motivation
- Time management skills
Timeline
Sterility Assurance Scientist
Integra Life Sciences
12.2023 - Current
Sterilization Specialist- Microbiologist
Integer Holdings
07.2023 - 12.2023
Remote Microbiology Consultant
ProPharma Consultant
06.2022 - 11.2022
Senior Microbiologist
Ion Labs Inc.
05.2021 - 08.2023
Product Specialist/Sterilization Lead
TUV SUD
01.2020 - 12.2020
Sterilization Specialist- Microbiologist
Oscor Inc
04.2017 - 01.2020
Medical Technologist II
HCA ST Petersburg General
03.2016 - 04.2017
Master of Arts - Elementary Education
University of Phoenix
05.2010 - 04.2012
Regional Manager of Manufacturing and Lab
United Blood Service
05.2010 - 03.2016
Laboratory Manager
Cascade Reginal Blood Service
09.2009 - 05.2010
Laboratory Manager
Cryo-Cell Inc
07.2005 - 09.2009
Quality Engineer Microbiologist
Cryo-Life Inc
06.2003 - 07.2005
Quality Microbiology Engineer
Bausch and Lomb
06.2001 - 06.2003
Microbiology Supervisor
Genzyme
06.1997 - 06.2001
Master Business Administration -
University of Phoenix
Bachelor of Science - Biology/Chemistry
Fitchburg State College