Project Management Maintenance

Mark R. McDonald

**** ****** *** ***** *** *** Minneapolis, MN 55408 216-***-**** acxozr@r.postjobfree.com

Microbiologist/Sterilization Specialist

Career Summary

More than 2 years experience as a microbiologist in the lab, and 1 year of experience as a microbiologist in the project management setting – Lab experience with sterilization and infection prevention research and development. Project management experience with sterilization of cardiac based devices. In depth knowledge of microbiology techniques, standards, practices and operation/maintenance of associated equipment. Skilled at interpretation of results and drawing proper conclusions. Great ability to develop experiments/plans, research current techniques or processes and then apply them to problems at hand. Great communication skills when presenting results and updates even to others not directly involved in work. Excellent knowledge of basic and more advanced microbiology skills (see technical skills for a more detailed list).

Education

The College of Wooster, Wooster, OH

Bachelors Degree in Biology, May 2013

Senior Thesis: Conducted an independent research study at the College of Wooster, which consisted of training rats and testing how their strength and endurance are affected by a growing workout supplement L-Arginine.

Honors: Deans Scholarship Award, Jim Kennedy Award Winner (2013) – given to the football player who has best shown excellence in academics, athletics, and personal life.

Technical Skills

Ethylene Oxide (EO) sterilization processes management, Microorganism Fine Printer (Dimatix), Hamilton Inoculation/Dispensing unit, Steam Autoclaves, Vaporous Hydrogen Peroxide Sterilizer (VPRO Max), Peracetic Acid Based sterilizer (System 1E), Ultra Violet Light Based Sterilizer (Pathagon), Glucose Bioanalyzer (YSI 2950), Spectroscopy, pH Meter, Dilution Series, Calibration, Hazardous chemicals, Transforming E. coli, Optical Microscopy, Atomic Force Microscopy, Gram staining, Isolating colonies, Replica plating, Preparing Media and Buffer, Knowledge of GLP/GMPs, Excel and other Microsoft programs.

Experience

Sterilization Specialist

Medtronic, Fridley, MN March 2016 - Present

•Responsible for designing/writing rationales, plans and reports for many ethylene oxide (EO) sterilized medical device submissions.

•Setup and managed various tests including bioburden, endotoxin, residual (EO/ECH), TCL, Irritation, bacteriostasis, and sterility.

•Conducted various meetings with project teams, leaders, and associated experts to give accurate timelines for testing and updates on current progress.

•Consulted with various project teams to give advice on testing and routes forward based on current standards and practices.

•Established device build, test sample, as well as machine maintenance and sterilization process traceability.

Associate Scientist

Steris Corporation, Mentor, OH 2013 – Jan 2016

•Ensure current and future products meet specifications set by the FDA and can perform their functions consistently and reliably.

•Involved in various forms of testing for the research and development of biological indicators, including but not limited to resistance testing, simulated use testing, reduced incubation testing, etc.

•Set up various Independent experiments in order to answer and/or explore problems with current products in development and determine potential solutions.

•Wrote and revised standards of procedure and test protocols depending on how the product adapts to various needs or wants of the organization and got documents approved and into the data storage system.

•Ordered reagents and materials required for daily lab usage and materials required to perform other specific test procedures.

•Responsible for keeping lab equipment calibrated and up to date on preventative maintenance to ensure quality data collection and extend the life/usage capabilities of the equipment.

• Worked in an FDA regulated facility and developed good laboratory practices.

•Established good sterile technique.

Lab Technician 2013

•Worked independently and conducted testing/reported results on a timely manner to supervisor.

•Performed various lab techniques and tasks including serial dilutions, enumerations, resistance testing, preparation of buffers/solutions, preparation of media, operation of vaporous hydrogen peroxide units, sterilization using steam autoclaves, gram stains, microscope operation and picture taking, data collection/recording, etc.

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