Senior Consultant, Biologics Consulting Group, Inc., Sanford, NC.

Manager, Quality Assurance, Biolex, Inc., Pittsboro, NC

• Provided oversight and improvements of the quality systems for a 2-product facility.
  
• Tracked nonconformances and trends, deviations, investigations, CAPA, and Change Control.
  
• Oversaw the administration and review of documents to include: Batch records, SOPs, protocols, and other technical documents.
  
• Responsible for batch release and issuance of certificates of compliance by accurate and timely review of all batch records, solution records, in-process data, release data and certificates of analysis.
  
• Mentored and coached systems administrators and quality specialists.

Senior Manager, Quality Assurance and Control, Embrex Poultry Health, LLC, Laurinburg, NC.

• From start-up to pilot licensing serials, established in less than 6 months a staffed and trained QA/QC Department for a start-up poultry vaccine facility.
  
• Developed and implemented Quality Assurance and biosecurity programs, strategies and processes to ensure product safety and biological containment.
  
• In accordance with 7 CFR and 9 CFR established QC procedures to ensure accurate and valid data for purity, safety, efficacy and potency tests.
  
• Ensured manufacturing procedures and documentation were in compliance with regulatory requirements. As Head Government Liaison maintained timely correspondence and accurate regulatory documentation.
  
• Designed and participated in Research & Development animal protocols and laboratory experiments for Field Safety submissions.

Quality Manager, Systems Administration, Bayer Corporation, Clayton, NC.

• Directed a department staff of 30+ personnel, managed $4 million budget, and served as Subject Matter Expert for several disciplines within the department.
  
  • Managed the Stability Department to support clinical trial material, and 12 commercial products, which included 1000+ active stability programs.
    
  • Managed the Standards and Controls program to qualify and provide expiry dating for product in order to assure test methods were properly validated and maintained a state of control.

Project Manager, Quality Assurance Release and Compliance Systems, Bayer Corporation, Clayton, NC.

• Provided Quality Assurance and Technical Oversight for the Animal Facility, Quality Control and Analytical Support
  
  • Managed and reviewed Change Control systems, Discrepancy and Failure Investigations, and Corrective Actions in order to assess batch disposition and product impact.
    
  • Reviewed Technical Registration Documents, assay development, and assay and equipment validation documents.
    
  • Served as a site 'super-user' and trainer for Trackwise.
    
• Enforced Site Compliance and Supported Product Release
  
  • Trained the laboratories on pertinent Quality procedures in order to stay current with FDA and industry practices.
    
  • Supported CQA, internal audits, and GCA, FDA, and PAI inspections and commitments.
    
  • Ensured monthly product release schedule was maintained.
    

Manager, BioAnalytical Methods Development and Quality Control Laboratories, AlphaVax, Durham, NC.

• Established Quality Control and Development laboratories
  
  • Developed and optimized viral test methods from Research & Discovery to Development & QC.
    
  • Ensured timely testing of stability, clinical trial intermediates and final dosage material.
    
• Established a Quality Function for a start-up biotechnology company specializing in HIV, and cancer vaccines
  
  • Implemented Standard Operating Procedures, Standard Test Methods, Cell Bank and Batch Productions Records, and Product Specifications.
    
  • Served as compliance oversight for the release testing laboratories.
    
• Performed Regulatory oversight
  
  • Provided technical documentation for the CMC sections of IND/CTX, NIH grants, Investigator Brochures.
    
  • Educated and trained Research & Discovery on cGMPs, USP, ICH, and FDA guidance for Contract Services to include: animal testing, contract manufacturing, and product
    

QC Senior Supervisor, Microbiology, Wyeth-Lederle Vaccines and Pediatrics, Sanford, NC.

• Managed and mentored ~10 laboratory staff
  
  • Responsible for $6.2 million budget expansion of new 10,000 sq. ft. laboratory, equipment purchases, labor cost forecasts, and hiring of personnel to support new vaccine launches.
    
  • Responsible for release of commercial product, bulk intermediate, and clinical trial material.
    
• Improved Analytical and Microbiological laboratory compliance
  
  • Provided technical support to Product Development and Technical Services, participated in PAI submissions, FDA and other international inspections

Research Associate II, Bacterial Vaccine Development, Wyeth-Lederle Vaccines and Pediatrics, Sanford, NC.

• Developed, and validated assay methods for bacterial vaccine candidates
  
  • Provided data, statistical analyses, and reports on analytical development to support new vaccine candidates and patents.
    
  • Analytical expertise: Chromatography: HPLC and GC, atomic absorption spectroscopy, proton NMR, UV/VIS, electrophoresis, wet chemical, and enzymatic assays.
    
  • Microbiological expertise: cell culture, ELISA, western and slot blot, and cell toxicity assays.
    
• Recipient of the American Cyanamid Special Achievement Award

Research Associate I, Process Chemistry Development, Wyeth-Lederle Vaccines and Pediatrics, Sanford, NC.

• Developed processes to prepare and purify vaccine candidates for Haemophilus influenzae type b and Streptococcus pneumoniae (7 serotypes)
  
  • Responsible for preparation of clinical trial material in accordance with cGMPs, and provided process improvements to support manufacturing.
    

Medical Technologist/Biochemist, SmithKline & French R&D, Philadelphia, PA.

• Key member of the Pathology/Toxicology drug team
  
  • Performed animal venipuncture, dosing and testing to screen pre-clinical drug candidates.
    
  • Conversant with GLPs.
    
• Performed cell culture, hybridoma selection, and mAb purification
  
  • Developed ELISAs to detect presence of pesticides for FDA.
    
  • Developed reverse phase methods for drug metabolites, and performed pharmacokinetic animal studies.
    

Laboratory Officer/Medical Technologist, US Army Reserves

• Received ROTC commission as a 2LT
  
  • Graduated Army's Basic Airborne School, Fort Bragg, NC.
    
  • Graduated Medical Service Corp, Officer's Basic Course, Fort Sam Houston, TX.
    
• Officer In-Charge (OIC), 361st EVAC Hospital, Philadelphia, PA
  
  • Performed STAT testing, crossmatches, antibody screenings and atypical antibody problem solving for the immuno-hematology laboratory.
    
  • Responsible for personnel and laboratory readiness during peacetime and at war.
    
• Individual Ready Reserves
  

Page Updated: June 16, 2008