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Thomas R.

Bauer (320) 493-2271

Summary of Qualifications
Results oriented biotechnology/medical device product development professional with a microbiology and lyophilization technology background. Leader of a team that has a track record of creative thinking and problem solving that has lead to breakthroughs and new ideas for revenue producing product development. Manage the design, development, and improvement process for a biotechnology company that has over 800 microorganism strains in various lyophilized formats for quality control. Adept with following the design control process and managing the process in an organization accredited to ISO 9001, ISO 13485, ISO 17025, and ISO Guide 34 for the design, development, production, biological testing, and distribution of In-Vitro microorganism preparations. Produce products and create processes in compliance with FDA regulations for In-Vitro medical diagnostic products, follow cGMP, and that adhere to CE Mark Conformity for In-Vitro diagnostic products in the European Market Goal oriented and a self learner that performs duties with minimal supervision. Prioritizes to meet revenue projections and provide the best possible products according to the needs of the customers, the Executive Team, Sales, and Marketing.

Selected Professional Accomplishments

2013 Managed the design, development, validation, and implementation of a shelf life and stability improvement for a key product line. The proprietary formula and process will allow for up to a 50% increase of the shelf life of the product and dramatically reduce customer complaints and product failures. Customer confidence in the product and company increased, as well as the increased ability to compete in the marketplace. 2012 - 2013 Developed a proprietary process for the successful preservation of Helicobacter pylori by lyophilization. This will allow Microbiologics, Inc. to be the only company in the world to offer a viable lyophilized preparation of this species. H. pylori is a strain that is notoriously hard to grow and preserve for long term storage. This is an extremely important product for clinical testing labs and has been requested for years. 2011 - 2012 Streamlined the production process at Microbiologics, Inc. Better efficiency was achieved without a detrimental effect on product quality. The cost savings (materials and labor) have been saving the company nearly $6,000 per year since implementation

Work Experience
Microbiologics, Inc. Saint Cloud, MN
Microbiologics is a leading provider of lyophilized biomaterial derivative products from microorganisms.

Research and Development Manager

September 2012 present

Lead a team of development scientists and report directly to VP of R&D (who is offsite) Direct the activities of the scientists and supervise their experiments and studies Peer review all studies and projects Hold monthly product pipeline update meetings for the executive team and senior managers Follow the design control process to ensure quality and regulatory requirements are met Hold design review presentations at development milestones as required by design control process Write and perform process and design VnV (verifications and validations) Maintain the design history files

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Thomas R. Bauer (320) 493-2271 Cost analysis of new product designs to ensure that minimum gross profit margin requirements are met Support the production team and continually improve the production and lyophilization process Support the Sales and Marketing teams by answering technical questions and keeping them up to date on product launch timelines Maintain relationships with key customers when developing a custom product or a product in partnership with another company July 2010 September 2012

Research and Development Technician (scientist)

Designed experiments and performed studies to improve the product lines and developed new product formats Cultured and developed lyophilized formats of private strains sent in by customers for the Custom Solutions program Researched and determined the best growth/culture conditions for all new strains being added to the product lines Trouble shoot experiments and product failures Wrote and performed process validations Performed shelf life studies September 2009 July 2010

Clinical Quality Control Technologist

Performed QC testing on products to ensure identity and concentration specifications were met Phenotypic testing (biochemical, microscopy, and also adept with Biomrieux Vitek 2 instrument for organism identification). Utilized Spiral Biotech Autoplate 4000 and QCount technology to determine the concentration level of the lyophilized bacterial preparations Produced accurate and consistent results in a laboratory accredited to ISO 17025 for its test methods Completed paperwork and released the tested organism for resale in accordance with our quality management system Spring 2005

St. Cloud Hospital, St. Cloud, MN

Histology and Clinical Lab intern

Learned to use a microtome to cut cross sections of wax embedded tissue samples Prepared biopsy tissue microscope slides with these cross sections and delivered them to the pathologist Shadowed in all areas of the histology and clinical labs


Bachelor of Science, Microbiology University of Wisconsin - La Crosse, La Crosse, WI Minors in Chemistry and Spanish Language Universitas Castellae, Valladolid, Spain Studied Spanish language, art, and culture 2005 / 2009 Summer 2007

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References available upon request


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