Samir Dave

About Samir Dave

Master’s of Science in Microbiology• Microbiologist with more than 7 years of experience in the field of quality and research• Project Team Leader for bioassay validation• Team member for validation activities such as microbial limit test validation, preservative effectiveness validation, and lab instrument validation• Experience with validation and implementation of rapid microbiological methods such as BD FacsMicrocount• Knowledge of working with advance instruments such as Vitek 2 bacteriological identification system for microbial identification • In depth knowledge of protocol writing and implementation• In depth knowledge in the field of fermentation for scale up, strain improvement, and process monitoring• Performance of microbiological tests of finished, raw material and stability samples in accordance with SOPs and cGMP regulations• Experience in performing various microbiological tests such as microbial limit test, preservative effectiveness testing, bioburden testing, container closure, bioassay, environmental monitoring, water analysis, particulate matter, bacteriostasis and fungistasis testing and sterility testing• Data analysis with the use of multiple statistical tools• Participation in review of lab documents and regulatory audits• Knowledge of computer and database programming• PhD candidate with thesis work in the field of protein and oxidative stress biomarker.Developed different techniques of protein precipitation and purification and worked on different techniques such as ELISA, PCR, and gel electrophoresis

Experience

1. Associate Director Contamination Control

   FUJIFILM Biotechnologies

   Mar 2022 — Present

Education

• University of Mysore

  Master of Science (M.Sc.), Microbiology

Skills

• Microbiology
• Quality Control
• Gmp
• Motivation
• Scale Up
• Fermentation
• Bioreactor
• V&V
• Molecular Biology
• Immunology
• Biotechnology
• Elisa
• Validation
• Biochemistry
• Environmental Monitoring
• Motivated Self-Starter
• Hplc
• Project Management
• Gel Electrophoresis
• Rapid Microbiological Methods
• Aseptic Technique
• Sop
• Fda
• Strain Improvement
• Proteomics
• Biostatistics
• Teamwork
• Particulate Matter Testing
• Lims
• Pcr
• Electrophoresis
• Laboratory
• Biopharmaceuticals