QUALIFICATIONS Seasoned professional with extensive experience in in-vitro diagnostic laboratories in the medical device manufacturing industry: 1. MULTIPLEXED ELISA DEVELOPMENT AND PRODUCTION 9. DATABASE DEVELOPMENT AND ADMINISTRATION 17. LAB PERSONNEL MANAGEMENT 2. FDA 510 (K) SUBMISSION PREPARATION 10. DESIGN AND CONDUCT PROCESS VALIDATIONS 18. DIAGNOSTICS CLINICAL TRIALS 3. AUTHOR GMP DOCUMENTATION AND PROCEDURES 11. SIZE EXCLUSION COLUMN CHROMATOGRAPHY 19. QUALITY SYSTEM DESIGN CONTROL 4. CONDUCT TECHNICAL MEETINGS AND BRIEFINGS 12. CUSTOMER TECHNICAL SERVICE 20. ENZYME-ANTIBODY CONJUGATION 5. BIOTECHNICAL MANUFACTURING TROUBLE SHOOTING 13. TANGENTIAL & NORMAL FLOW FILTRATION 21. UV-VIS SPECTROPHOTOMETRY 6. IFA TECHNIQUES WITH MICROSCOPY AND IMAGING 14. ANTIGEN IMMOBILIZATION TECHNIQUES 22. SDS-PAGE AND WESTERN BLOT 7. SOFTWARE APPS: FILEMAKER, MS OFFICE & PROJECT 15. PROTEIN DIALYSIS AND CONCENTRATION 23. INSTRUMENT DATA PROCESSING 8. CELL CULTURE PRODUCTION SCALE-UP METHODS 16. VIRUS PRODUCTION AND DEVELOPMENT 24. DNA EXTRACTION
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