SUMMARY:

• Accomplished Scientist - Microbiologist with experience in a variety of fields including Pharmaceutical Quality Control, Sterile Manufacturing, Research and Development -Clinical Laboratory Analysis, Medical Technologist and Quality Assurance and Quality Compliance. Excellent skill in computer and instrumentation. Recognized as an adaptable team member known for project flexibility and delivery of results.
• Microbiology DATA Reviewer for CDMO- Contract Drug Developmental and Manufacturer.
• Antimicrobial Drug Discovery and Development support for Phase III-IV compounds -Doribax, Ceftobiprole and Levofloxacin. Perform in vitro Antimicrobial Susceptibility testing by MIC, Disk and ETest (CLSI) method. Microbial Identification by Vitek2, API and Rapid methods. Presentation of research data and journal articles at group meetings.
• QC Microbiology: Raw Material, In-process Bulk and Finished - Sterile Parental, Topical, Oral (Solid - liquid dosage forms) MD & Diagnostic (Blood Bank) Products. Manage Stability Program. cGMP, cGLP.
• PPQ: Test Method Validation. IQ, OQ and PQ for new automated equipment for more accuracy and reduce cycle time. Validation of Autoclave, Incubators. Cleaning Validation. Design CLEAN Room Environmental Monitoring specification for sterile manufacture facility.
• Quality QA Compliance. Review, assess compliance to documents and change control process.
• Medical Laboratory Technologist: Experienced in various departments including Hematology, Serology, Chemistry and Microbiology RAST assay for allergy test- Radio Immuno Assay
• Proficiency in computer systems. Microsoft Office- Word, Excel and Power Point.

PROFESSIONAL EXPERIENCE:

Confidential, Lakewood, NJ

Data Reviewer

Responsibilities:

• Review data for various Microbial Test and Validation for different client. Collect department data.
• Face to face interactions, not just sending email to people collecting data . Develop best practices and possibly implement procedures where needed.
• Review Results on line - MODA Application (Mobile Data Acquisition).
• Release Components Finish Product through QIS System Quality Information System.
• Communicate with QA for any issue. Check Track wise for PR Problem Report. Scan Results to CSL (Computerize Sequential Log System).
• Perform tracking and trending of lab data.

Confidential, Piscataway, NJ

Microbiologist On Assignment (Consultant/Contactor)

Responsibilities:

• Perform microbiological testing of finish goods, bulk, and raw materials in accordance to GMP, CTFA, PCPC and FDA requirements. Isolation and identification of microbial growth to determine acceptance /rejection criteria. D Count Flow Cytometry, Water testing.
• Intense use of SAP application for product release and Quality Priority Report.
• Communicate with various QA departments to complete the job.

Confidential

Sr. Quality and Compliance Associate

Responsibilities:

• SME - (Subject Matter Expert) Review various Microbiology and Environmental Procedure for compliance prospective. Document Assessment, Red line document, Get approval and send for
• Change Order -Track documents- Train appropriate audience and make sure it's implementation.
• QA documentation activities such as document change control tracking and completion
• Review proposed changes to documents and assess compliance to document and change control processes.
• Process documents through Document Control using Agile and SharePoint.

Confidential, Raritan, NJ

Scientist - Microbiologist

Responsibilities:

• QC Microbiology product release group. Testing (Bioburden - Total Plate Count by Pour pate,
• Membrane Filtration and MPN, Review and Releasing (ERP/SAP System) various Blood
• Bank Reagents such as Antigen detecting reagent, Antibody screening (Red cell containing reagent) Donor Screening (Aids/Hep) and Cell Search Reagents, RhoGam (Neonatal hemolytic disease) Immuno globin product. Using MD& D guideline.
• Microbial Water testing and Limulus amebocyte lysate ( LAL) Bacterial Endotoxin Test.
• Review SOPS. Support OOS, Data Tracking and Trending Reports.
• Enhanced Ergonomic Process for test method using Milli snap/ Milliflex Plus System.

Confidential, NJ

Research Associate Scientist

Responsibilities:

• Antimicrobial Susceptibility Testing - AST by broth microdilution MIC, Disk testing and
• E test following CLSI (Clinical Laboratory Standard Institute guidelines) methodology.
• Instrument: BioMek FX robot, Trek Sensititre Vizion System and Microbial ID Vitek2.
• Generated and analyzed data for initial meetings, creating spread sheets, graphs and charts.
• Present article Routine Identification of Bacteria by Matrix-Assisted Laser Desorption
• Ionization Time-of-Flight Mass Spectrometry.
• Recognized in Team for Maintaining Clinical Isolates and Database.

Confidential, NJ

Associate Scientist - Microbiologist

Responsibilities:

• Performed Microbial Testing and release products according to specification in timely manner.
• Microbial Limit Test/Bioburden
• USP <61> <62>
• Vitek2/API
• USP <1113>
• Preservative Effectiveness
• USP <51>
• ATP Bioluminescence - Celsis
• Bacterial Endotoxin (LAL-Gel)
• Aseptic filling/CAMA
• Bioassay-Antibiotic
• Microbial Water Testing
• USP Compendia/CFR/EP/BP
• Sterility Testing
• Growth Promotion
• FDA/CBER
• Bacteriostasis Fungistasis
• ATCC culture collection
• LIMS/NOR/NCS/OOS
• Disinfectant Study
• Validation PPQ/Calibration
• Writing SOP/Trackwise
• Biological Indicator
• Environmental Monitoring
• Microsoft Office
• Changed dilution method for Erythromycin Antibiotic Assay. Resulted in cost savings for expensive USP Standard.
• Performed Requalification of Media by Growth Promotion Testing- extending shelf life of media. cost savings for company.
• Eliminated extra testing for water activity of suppositories; showing data trending results and
• Suppositories were not a part of USP requirement for water determination.
• Presented article on Antimicrobial Preservative Efficacy testing for improve test method and cost saving approach.
• Revise SOPs and Test Method Procedures. Review data. Write Protocol.
• LIMS Laboratory Information Management system - end user feedback to create module and
• Performed Scientific Review for software.
• Received three awards for Team Work.

Confidential

Responsibilities:

• Validated automated Steriscreen, which increased accuracy and reduced product testing time to four days.
• Qualification of BioMerieux Viteck2 Micro Organism Identification System.
• Test Method Validation (Preparatory Testing/ Method Suitability for Product Inhibition) Raw
• Material and Finish Products.
• Qualified Disinfectant (Effectiveness study) and Biological Indicators.
• Evaluation of Environmental Recovery Method Effectiveness.