Nathan Kofahl Email & Phone Number

Minneapolis, Mn, Us

Minneapolis, Mn, Us

Minneapolis, Mn, Us

•Managed laboratory performing Bioburden, Bacterial Endotoxin Testing (BET), Microbial Characterizations, Hemolysis, Cytotoxicity testing along with Environmental Monitoring of controlled environments. Leveraged knowledge of R&D, Production, and QA & QC needs to maintain, upgrade capabilities and recommend improvements to support business and technology strategies. Partnered to advance and accelerate projects by staff training, timely service scheduling, maintaining capacity, and supporting audits. Oversaw two Microbiologists and two Micro technicians, plus a Quality Engineer (dotted line). Performed annual reviews and assisted with professional development plans. Responsible for annual budget and 10Q projections. - Led the lab team in transition of laboratory processes all test methods, Quality Control, and reporting processes to Matrix Gemini LIMS system. Met transition target deadline and added material and equipment traceability within LIMS. - Reduced by >50% OOS closure time after implementation by streamlining Out Of Specification (OOS) investigation and documentation process using LIMS system. The new process was adopted in all GLS Microbiology labs in the US. - Selected to oversee the sterilization process that caused the dose audit failure in Puerto Rico site. Investigated multiple processes and identified the root cause of the sterilization failure. Averted potential loss of $11M in revenue. - Managed project with national team of SMEs to harmonize test analyst training and test method qualification process. - Trained new Microbiologists on method verification, OOS investigations, Nonconformance investigations, CAPA and more. - Prepared laboratory for ISO 17025 Accreditation.

Minneapolis, Mn, Us

Served as CAPA owner and SME for root cause analysis, risk mitigation, and corrective & preventive actions. Consulted R&D teams on issues related to radiation and ethylene oxide sterilization. Mentored and developed junior microbiologists; managed a budget. - Identified a high-risk microbial contamination of glucose sensors. Led cross-functional team to identify root cause, established new cleaning procedures and preventive in-process testing. As a result, completely eliminated microbial contamination. - Developed new Clean In Place (CIP) machine and cleaning schedule resolving equipment contamination with radiation resistant bacteria; collaborated with the Engineering and consulting teams. - Reviewed internal and supplier process/equipment changes for impact on sterilization and microbial cleanliness. Managed assessment and testing required for changes. - Supported Medtronic’s Global team developing tools for risk mitigation associated with radiation resistant microbes and dose audit root cause investigations.

Managed microbiology laboratory and microbiologist on staff, responsible for environmental monitoring of ISO Class 7 cleanrooms, bioburden testing, sterility testing, microbial identifications, glutaraldehyde concentration analysis, and Tg thermal analysis of materials. Supported notified body, microbiology audits as SME. - Designed, executed, and documented sterilization validations of ethylene oxide, radiation, liquid chemical, and steam. - Performed biological risk assessments on Class III medical devices in compliance with current ISO 10993 requirements. - Coordinated and evaluated viral inactivation studies supporting bovine pericardial tissue processing. - Performed quarterly internal audits of Quality Management Systems resulted in findings with corrective/preventive actions. - Managed backroom activities supporting external audit of the entire QMS.

• Managed sterilization (EO, gamma) and biocompatibility program. Responsible for cleanroom qualification, routine microbiological testing, and excursion investigations. Supported internal & external audit, supplier qualification, CAPA and NCR management. - Determined flaw in manufacturing of Process Challenge Device (PCD) used to confirm validity of ethylene oxide sterilization process.

Consulted on various projects related to:Ethylene Oxide, Radiation and Liquid Chemical sterilization validations,Biological risk assessments in compliance with ISO 10993-1 and FDA Guidance,Environmental Monitoring compliance with ISO 14644Microbial contamination investigations,Internal QMS audits, contract laboratory and sterilizer audits,Support with regulatory submission reviews and responses to FDA or Notified Body queries

Santa Rosa, California, Us

Managed Sterilization and Biocompatibility program for all products including permanent implants, external communicating devices and accesories.Responsible for:-Ethylene Oxide, Radiation, and Liquid Chemical sterilization validations and periodic requalifications.-identifying and qualifying new contract sterilizers.-product adoptions into existing sterilization cycles-evaluation of product changes and their impact to sterility-evaluation of product change impact to product biocompatibility-design/execute biocompatibility test strategy including material characterization and biological testing for new products based on patient exposure and target geographies-consult R&D teams on material selection for new and existing products-author test protocol/reports for all sterilization and biocompatibility studies-author/review biocompatibility and sterilization sections of regulatory submissions.-serve as company wide SME for all biocompatibility, sterilization, environmental monitoring and microbiology related issues.Managed environmental monitoring program for Class 7 and 8 CERs at multiple sites-managed program to ensure compliance with ISO 14644-1:2015-designed and implemented failure response procedure for all environment monitoring-evaluated changes to CERs and determined relevant recovery testing Managed internal QC microbiology laboratories performing bioburden, sterility testing, LAL sample prep,and and sterilization batch release for commercial/clinical productDeveloped/Managed External Standards monitoring and gap analysis programInternal Auditor, performed manufacturing line audits, vigilance and medical device reporting, and general compliance to ISO 13485 and FDA's CFR. External Auditor, responsible for auditing of contract sterilizers, and test labs

Minneapolis, Mn, Us

- coordinate biocompatibility studies in compliance with ISO 10993, MHLW and FDA requirements- evaluate product improvements and vendor changes for their potential effects on existing sterilization validation and biocompatibility- validate ethylene oxide, and e-beam sterilization cycles in compliance with ISO 11135 and ISO 11137 respectively- audit contract test labs and sterilizers- author/edit product submission for 510K/IDE/PMA/CE Mark/Shonin submissions and respond to questions related to biocompatibility testing and sterilization validations- perform Bioburden, LAL, Cytotoxicity, Hemolysis, and FTIR testing along with microbial identifcations (gram staining, catalase testing, oxidase testing, endospore staining)-manage and participate in pan-Medtronic groups creating SOPs relating to Sterilization Validation, Product Release post sterilization, and Bioburden testing.

Santa Rosa, California, Us

Teaching both Lecture and Lab covering topics including:Lecture:-History of Microbiology-Basic Biochemistry-Prokaryotic and Eukaryotic diversity-DNA replication, gene expression and mutation-Microbial growth and microbial control-Bacterial genetic recombination-Antibiotics-Emergence of antibiotic resistance-Viruses-Epidemiology-Mechanisms of microbial pathogenicity-Innate and Adaptive Immunity-Applied MicrobiologyLabs:-Aseptic technique-Gram and simple staining-Coliform testing-Use of various Selective, Differential, Enriched and Complex media to identify common clinical pathogens-ELISA testing-Catalase testing,slide preparation for determining bacterial motility (hanging drop)-Streak plating to grow pure cultures and describe colony morphologies-Agarose gel electrophoresis-plasmid transformation experiments with competant strains

M.S., Animal Physiology

B.A., Marine Biology