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Microbiologist Resume

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Elkton, MD

SUMMARY:

  • Senior Microbiologist
  • Microbiologist Scientist Quality Control Technician Pharmaceuticals Group Leader
  • World - class pharmaceutical and medical device industry experience across new product development, testing, and process monitoring disciplines.
  • Subject Matter Expert for existing and emerging technologies.
  • Creator/author of lab processes, testing methodologies, and QA protocol to meet continuous improvement.
  • Leader/Manager of laboratory operations for contract microbiology and analytical testing across pharmaceutical, nutraceutical, and surgical implant industrial clients.
  • Recognized for professional research and 21 scientific journal publications to date.

CORE COMPETENCIES:

  • Regulatory Compliance Validation Test Method Transfer
  • Laboratory Investigations Quality Assurance Microbial Limits Testing
  • Microbial Identification Audit Support Bioburden
  • OOT/OOS/CAPA Investigations Inventory Management Endotoxin (LAL)
  • USP/ISO Methodologies Quality Control Cytotoxicity
  • Trending Data Research cGMP Document Control

PROFESSIONAL EXPERIENCE:

Confidential, Elkton, MD

Microbiologist

Responsibilities:

  • Testing Center team member that originated testing methodologies procedural changes.
  • Organized/facilitated Cell Culture and Cytotoxicity Workshop for Gore associates.
  • Created/authored/reviewed/revised SOPs and laboratory investigations.
  • Committee/Panel member for Safety Improvement and Lab Effectiveness initiatives.
  • Established East Coast Testing Center as a Biological Safety Level 2 (BSL-2) laboratory.
  • Directed establishment of laboratory’s Vendor Managed Inventory (VMI) program.
  • Authored the ‘Biological Safety’ section for revised Chemical Hygiene Plan.
  • Qualified 3 incubators, and validated (OQ/PQ) benchtop water purification system, and performed routine lab equipment preventative maintenance/monitoring.
  • Collaborator for “MPD Chemical Characterization Root Cause of Cytotoxicity” technical presentation.

Confidential, Ft. Washington, PA

Scientist I

Responsibilities:

  • Performed finished product/raw material microbial limits testing and water activity testing in support of pharmaceuticals manufacturing.
  • Collected/tested environmental monitoring and cleaning validation samples for QA/QC.
  • Executed microbial identifications utilizing VITEK system.
  • Utilized LIMS for sample receiving and test data entry.
  • Executed QA data and logbook review, and inventory management.

Confidential, Frederick, MD

Quality Control Technician II

Responsibilities:

  • Member of a select team supporting the validation of a corporate-wide biopharmaceutical manufacturing and R&D facility disinfectant use program.
  • Executed dilution-use and surface challenge studies evaluating disinfectant efficacy and suitability against Confidential and in-house microbial isolates.
  • Performed media quality control and sterilization of environmental monitoring supplies, maintained project working cultures, and prepared cryopreserved microbial stocks.
  • Director’s Award for exemplary performance, 2007.

Confidential, Boothwyn, PA

Pharmaceuticals Group Leader & Project Manager

Responsibilities:

  • Conducted microbiological and analytical testing operations for a contract testing facility.
  • Performed quality assurance, equipment qualifications, microbial identification, laboratory investigations, and routine maintenance.
  • Provided audit support. Attended client meetings.

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