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.
