Microbiologist, Scientist, R&D, FDA, Medical Devices

BETH REEVES

**** *** ***** **, ********, GA *****

443-***-**** cell

*************@*****.***

Work Experience:

**/**** – July 2016 Pharmavite Opelika, AL

Microbiologist II, 50 hrs per week

Perform microbiological analyses of raw materials, finished products, stability and special samples using a variety of instrumentation including bioMerieux VIDAS and Soleris. Ensuring product testing conforms with USP, EP, and JSP standards. Weekly collection and testing of DI water in manufacturing plant, testing for coliforms, total viable count, TOC, and conductivity. Compliance to SOPs. Writing and performing validations on all new equipment and troubleshooting. Conducting investigation on any test and/or assay failures. Perform general lab duties including cleaning and maintenance of work area and checking notebooks. Conducts scheduled calibration of lab equipment (such as pH meters, balances, etc). Submit accurate results by performing tests using the latest documentation. Maintaining inventory of all supplies including media. Preparing media for use in tests. Disposal of biohazardous wastes. Compliance to all safety and PPE requirements. Responsible for the preparation, standardization and documentation to be used in all microbiological analyses. Keeping Planning and Development Leadership Teams updated to all laboratory testing on raw materials and bulk products. DI Water and cleaning validations.

04/2006 – 01/2007 Adecco

01/2007 – 06/2013 Becton Dickinson Hunt Valley, MD

Scientist II, hours 40 hrs per week

Part of a molecular biology team for a series of multi-plex PCR diagnostic assays for Sexually Transmitted Diseases. Cell culture, growth, purification, and quantification using DFA of various viruses. Daily lab experiments using clinical samples including genital swabs, urine, blood, and interfering substances. In charge of organizing thousands of blood samples for major research project. Managing database of Clinical trial samples. Shipping materials and samples to testing facilities. BSL2 and BSL3 experience. Blood Born Pathogen training. In charge of receipt of infectious samples from external sites and distributing samples for testing. Certified for shipping biohazardous materials domestically and internationally. Responsible for maintaining cell lines for cell culture projects. Responsible for growth and maintenance of all organisms in collections. PCR and molecular testing. Troubleshooting in assay chemistry and instrumentation. Conducting validation experiments, writing protocols and summary reports that will be submitted to the FDA. Writing peer reviews, review of managers/supervisors, and self-reviews. Responsible for 19 month reagent stability study for FDA approved products. Wrote paper/poster and presented data at the Clinical Virology Symposium in May 2011.

1/2003-02/2006 Shire US Manufacturing, Inc. Owings Mills, MD

Microbiologist I, 40 hrs per week

Monitor viable particulate counts using RCS machines in the Potent Compound Suites and GMP Suites. Environmental monitoring with PAPR (Powered Air-Purified Respirator). Microbial Identification. Training on Vitek. Responsible for identifying fungal isolates captured from environmental monitoring. Aseptic collection and testing of potable water and USP purified water for presence of coliforms and total bacterial counts using membrane filtration and pour plates. Initiation and completion of “Out of Specification” notices. Strict adherence to SOPs. Aseptic techniques. Quality Control – sterility and growth promotion of incoming media and supplies, including organisms (Quanti-cults). Responsible for environmental monitoring data trending. Completed 40 hours of HAZWOPER Training (Hazardous Waste Operations and Emergency Response). Member of the Safety Committee.

4/2002-1/2003 Chesapeake Biological Labs Baltimore, MD

Microbiologist, 40-45 hrs per week

Monitor viable and non-viable particulate load in the clean rooms (Class 100). Personnel and environmental monitoring, with Climets and SMA units. Followed strict adherence to SOPs for all procedures. Used EMS (Environmental Monitoring System) software to create a database of EM information and trend results. Utilized aseptic techniques in all procedures. Performed bioburden testing of water and product samples using membrane filtration. Performed gel-clot endotoxin test on water and product samples. Performed Kinetic endotoxin test. Perform microbial quality control testing, i.e. growth promotion and cosmetic characteristics of the media, buffers, rinsing fluids, rodac and settling plates.

1/2001-4/2002 Kelly Scientific Resources Baltimore, MD

Research & Development Scientist, 40 hrs per week

(Assignment at Becton Dickinson, Sparks, MD)

Assisted in a research & development project involving a “table-top” identification instrument for hospitals, doctors’ offices, and laboratories. Experience in preparing instruments for experiments – buffer preparation, drug solubility, drug interactions with bacteria. Prepare plates for subsequent experiments – streaking plates for colony isolation, identifying contamination. Maintaining original data sheets and subsequent database from worldwide external instrument test sites. In charge of day-to-day running of lab for database generation – delegating tasks, maintaining adequate experiment supplies.

6/1999-5/2000 Baxter Hyland Immuno Thousand Oaks, CA

Quality Control Microbiologist, 45-50 hrs per week

Gained aseptic filling (Class 100) experience including gowning and environmental and personnel monitoring. Isolated colonies for identification. Held responsible for approving and distributing all city water, RO (Reverse Osmosis), and WFI (sterile Water for Injection) paperwork. Completed GMP, GLP, GDP and Quality Leadership Process (QLP) training. Gained experience with LIMS (Laboratory Information Management Systems). Followed strict adherence to SOPs for all procedures. Initiated Alerts and Actions for out-of-specification results. Performed product lot/batch release. Initiation and completion of notices of deviations to standard procedures.

Computer Skills: IBM/PC, Mac, Word, Excel, Access, Lotus notes, Microsoft Outlook, SAP, Freezerworks, SharePoint, LIMS

Education: BS Biology, California Lutheran University, May 1999, GPA 3.36/4.00

Johns Hopkins University Masters of Biotechnology program with a concentration in Biodefense graduate 2008

Special Skills: Certified Division 6.2, for Shipping Infectious Substances, Biological Substances, Genetically Modified Organisms, Dry ice, Liquid Nitrogen Shippers, Limited and Excepted Quantities

Papers and Presentations: Feasibility of Testing Specimens Collected for the BD ProbeTec™ CT/GC Qx Amplified DNA Assays on the BD MAX™ System Association for Molecular Pathology Phoenix, AZ Nov 2013

Detection of HSV1 and HSV2 DNA from External Anogenital Lesion Specimens Using the BD Viper™ System in Extracted Mode Clinical Virology Symposium, Daytona Beach, FL May 2011

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