Experience

MicroBio Consulting, LLC

• President & Consultant, Medical Device Sterilization, Microbiology, Biocompatibility, Toxicology

  • Aug 2017 - Present

  https://www.microbioconsulting.com/From the lab bench, to managing teams of scientists and engineers at leading Medical Device companies, I have a proven track record of using my strong technical background to drive biotech innovation forward while ensuring product efficacy and patient safety. Subject matter expertise including:Microbiology • Sterilization • Biocompatibility • Toxicology • Regulatory Compliance • International Standards • Risk Management • Material & Product Requirement Specifications • MDR Remediation • CAPAs • Verification & Validation • Chemical CharacterizationProficient in the following Standards and Regulations· ISO 11135:2014· ISO 11137-1, 2 and 3· ISO 11737-1 and 2· USP <71>· AAMI ST72:2011· ISO 10993-7:2012· AAMI TIR 28:2011· ISO 13485:2016· AAMI TIR 30:2011· ISO 17665-1:2006



Smiths Medical

• United States
• Medical Equipment Manufacturing
• 500 - 600 Employee

• Senior Manager of Global R&D Microbiology & Toxicology

  • 2014 - 2017

  •Lead & mentor microbiologists & toxicologists•Provide strategic direction for global microbiology, sterilization, biocompatibility & patient safety outcomes•Provide technical direction to all business units for project management for all new product introductions & design changes•Perform risk assessments, implement mitigation strategies, & evaluate effectiveness & efficiency•Recommend safe biocompatible sterilizeable materials•Write new & improved corporate policies & procedures related to microbiology, sterilization, biocompatibility, drug stability/compatibility, contamination control, incoming inspection, packaging requirements, cleaning/disinfection validation of reusable products, release programs for finished devices, controlled environments, patient safety, & supplier quality/approval•Standardize site procedures•Create & provide training programs in accordance with policies and procedures, as well as related international/national standards, across all business units•Subject matter expert in all microbiology, sterilization, & biocompatibility related test methods, standards, risk management requirements, material/product requirement specifications, & verification/validation requirements•Demonstrate knowledge in compliance with cGMP, FDA, CFR 820, ISO 13485, as well as industry best practices•Develop & implement sampling plans for incoming materials•Provide direct support in audits (internal & external), inspections, customer complaint investigations, customer requests, tenders, & CAPAs•Manage remediation of technical files•Present at international & national symposiums, conferences, & seminars•Promote visibility of Smiths Medical in MN via collaboration w/STEM, U of MN Medical Devices Center, MN Science Museum, Fox 9 News, & other local events•Proficient in project planning, master plans, & lean initiatives•Active member of TC 194 Biological &clinical evaluation of medical devices & TC 198 Sterilization of health care products



Olympus Corporation of the Americas

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Microbiology Manager

  • 2007 - 2014

  •Responsible for providing microbiological and toxicological expertise to Olympus worldwide and ensuring that operational and development teams adopt best practices.•Provide guidance for the design, layout, construction, control and monitoring of controlled environments for manufacture of reusable and disposable medical devices.•Thorough knowledge in the concept of internal and external regulatory requirements in the following subjects: microbial environmental monitoring, biocompatibility, contamination control, sterilization, six sigma, lean manufacturing, 5S, validation master planning, project management and quality assurance.•Provide guidance on the application of the internal and external regulatory and ISO standards.•Develop, implement, and maintain quality assurance system policies and procedures.•Responsible for conducting and responding to internal / external / registrar audits, customer complaints, corrective / preventive actions CAPAs, and nonconformances NCRs.•Established an In-House Microbiology Lab to support the continued growth of the company and associated increases in testing needs.•Manage Microbiology Specialist and Microbiology Laboratory Technician to include training, performance evaluations and compensation recommendations.•Develop, write, conduct, review and approve test method validation protocols and reports as well as equipment installation, operation, and performance qualifications.•Support regulatory submissions by conducting the final Microbiology and Toxicology review to ensure appropriate microbiology and biocompatibility information is present in the submission (to comply with ISO 10993, 11135, 11137, 14644, etc.)•Fully support the Quality Policy by building quality into all aspects of the Microbiology Lab and by maintaining compliance to all quality requirements.•Responsible for training all personnel on Good Hygiene Practices.•Establish and maintain budgets, goals and staffing.•Develop, track, and report metrics.



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Microbiologist

  • 2003 - 2007

  • Established new microbiology lab in Arden Hills, MN in response to increased testing needs due to acquisition of Guidant.• Developed and implemented new test methods resulting in over a million dollars in cost savings by in house testing.• Performed, coordinated, and approved microbiological and chemical tests performed in accordance with approved protocols/procedures/reference standards and wrote the final report.• Performed and coordinated environmental monitoring, bioburden and endotoxin tests using approved procedures/protocols and wrote the final report. Wrote, reviewed, and approved department SOPs.• Conducted new equipment qualifications and wrote, reviewed, and approved related SOPs.• Supported projects for continuous improvement in microbiology related practices within the Microbiology Laboratory and for other BSC sites as assigned.• Maintained laboratory inventory and managed purchasing of supplies as needed.• Provided microbiology expertise and validation support to other facilities worldwide.• Interfaced between outside testing laboratories and representatives from other departments, for various microbiological, biological, and analytical chemistry tests.• Performed data collection and analysis to monitor trends in test results.• Provided microbiology support for manufacturing changes.



Arizona Department of Health Services

• United States
• Wellness and Fitness Services
• 700 & Above Employee

• Epidemiologist for Bureau of Epidemiology and Disease Control

  • 2000 - 2003

  Designed & conducted epidemiological investigations to identify, isolate & control chronic, environmental & infectious diseases. Consulted with county health department to verify diagnoses & mitigate exposure. Analyzed statistical data & identified disease trends & characteristics. Prepared recommendation reports for control of specific diseases. Provided technical advice & assistance to new program staff. Developed, implemented & maintained disease surveillance programs & databases. Completed compendium of case data, study protocols & investigation plans, reports, including recommendations for control & eradication of diseases. Responded to requests for technical information from county health officers, physicians & the public. Completed epidemiological studies, which included reports outlining chronic or infectious disease outbreaks, causes, sources of exposure & recommendations for mitigation or control. Determined appropriate methods of disease investigation & surveillance, type of laboratory specimens & type of laboratory tests needed. Conferred with local government & private agency representatives, gathering information regarding features & conditions in locality. Wrote detailed reports based on research, analysis & evaluation of data pertaining to specific projects, conditions or proposals under study, involving application of expert or highly specialized knowledge & recommendations for action to be taken or resolution of problems. Wrote detailed environmental impact reports, based on own epidemiologic investigation & analysis of environmental conditions & effects. Designed & modified questionnaires & other data collection & sampling instruments of data summarization methods, procedures or reporting formats. Compiled information for & wrote periodic reports on own work activities. Contributed to grant writing & screening policies.



The Jackson Laboratory

• United States
• Biotechnology Research
• 1 - 100 Employee

• Biomedical Technologist for Diagnostic PCR Lab

  • 1999 - 2000

  Managed PCR diagnostic laboratory. Performed routine microbiology, serology, and parasitology diagnostic testing on transgenic mice. Designed PCR diagnostic tests and standards for various mouse diseases such as Pneumocystis, Mycoplasma, Helicobacter, Spironucleus, Pasteurella, and others. Maintained test results, records, and large databases. Directed the course of imported mice to be tested by the diagnostic lab. Supervised breeding colonies of certain transgenic control mice. Surveyed and investigated the epidemiology of the mice colonies. Consulted with scientific committees, pharmaceutical sales associates, and many research laboratories throughout the world. Trained and supervised new employees.



University of Minnesota

• United States
• Higher Education
• 700 & Above Employee

• Genome Sequencer for Veterinary Pathobiology Lab

  • 1998 - 1999

  Designed and performed research projects in order to sequence and publish the genomes of Cryptosporidium parvum and Pasteurella multocida. Used recombinant DNA technology. Obtained and analyzed gene sequencing results for construction of genomic map. Managed lab records. Trained and supervised student employees. Assisted in writing grants. Designed and performed research projects in order to sequence and publish the genomes of Cryptosporidium parvum and Pasteurella multocida. Used recombinant DNA technology. Obtained and analyzed gene sequencing results for construction of genomic map. Managed lab records. Trained and supervised student employees. Assisted in writing grants.



Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Veterinary Animal Care Taker for Physiological Research Lab

  • 1997 - 1998

  Cared for animals and prepared them for surgery. Performed measurements of weight, temperature, feeding, cleaning, and observation of animals. Maintained medical, surgical, and research records. Cared for animals and prepared them for surgery. Performed measurements of weight, temperature, feeding, cleaning, and observation of animals. Maintained medical, surgical, and research records.



Walgreens

• United States
• Retail
• 100 - 200 Employee

• Pharmacy Technician

  • 1996 - 1997

  Prepared pharmaceuticals for customers per doctor recommendations. Prepared pharmaceuticals for customers per doctor recommendations.