Samir Dave

Samir Dave Email and Phone Number

Associate Director Contamination Control at FUJIFILM Diosynth Biotechnologies @ FUJIFILM Diosynth Biotechnologies
Samir Dave's Location
College Station, Texas, United States, United States
Samir Dave's Contact Details

Samir Dave work email

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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

Samir Dave's Current Company Details
FUJIFILM Diosynth Biotechnologies

Fujifilm Diosynth Biotechnologies

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Associate Director Contamination Control at FUJIFILM Diosynth Biotechnologies
Samir Dave Work Experience Details
  • Fujifilm Diosynth Biotechnologies
    Associate Director Contamination Control
    Fujifilm Diosynth Biotechnologies Mar 2022 - Present
    Billingham, Gb
  • Fujifilm Diosynth Biotechnologies
    Manager Quality Control
    Fujifilm Diosynth Biotechnologies Jan 2020 - Mar 2022
    Billingham, Gb
  • Fujifilm Diosynth Biotechnologies
    Supervisor Quality Control
    Fujifilm Diosynth Biotechnologies Jun 2017 - Jan 2020
    Billingham, Gb
  • Alcami Corporation
    Supervisor
    Alcami Corporation Jun 2014 - Jun 2017
    Wilmington, Nc, Us
  • Akorn, Inc
    Microbiologist Ii
    Akorn, Inc Oct 2010 - May 2014
    Lake Forest, Il, Us
    • Mentor and train new staff• Quality control and launch investigation for out of specification results• Perform preservative effectiveness testing and method validation, preservative minimum level effectiveness testing, antimicrobial susceptibility testing , water analysis, bacteriostasis and fungistasis testing and microbial limit test• Perform particulate matter testing using HIAC PharmSpec 3 software• Experience with laboratory protocol and procedural development• Develop research plans for new projects• Develop knowledge and perform various microbiological tests such as bioburden, container closure testing, sterility testing and environment monitoring as needed• Document and maintain current good laboratory practices for company records and certifications/audits• Participate in various training activities within the company to stay current with new techniques• Prepare various microbiological media, buffers and reagents in the lab• Perform microbial identification using Vitek 2 bacteriological identification system• Responsible for method development and validation of water analysis and microbial limit test using BD FACS MicroCount• Coordinate protocol development, perform and validate bioassay• Maintain environmental and non-environmental isolates• Assist in cleaning and disinfection validation study• Team Member for Research and Implementation of Rapid Microbiological Method• Member of a cross functional team performing various validation and qualification activities like water system qualification etc.
  • Sardar Patel Universtiy
    Phd Candidate
    Sardar Patel Universtiy Apr 2009 - Mar 2010
    • Conducted research to isolate urinary biomarkers for diabetic nephropathy.• Research experience to evaluate level and effect of oxidative stress using serum and other biomarkers• Graduate assistant and lecturer for undergraduate students in Immunology, Biochemistry and Microbiology• Participated in laboratory projects involving ACE polymorphism and arsenic toxicity• Developed methods for protein precipitation and purification, electrophoresis, polymerase chain reaction, ELISA, fast protein liquid chromatography for application to daily research
  • Sterling Biotech Ltd.
    Executive Microbiologist
    Sterling Biotech Ltd. Jan 2008 - Apr 2009
    • Supervised instrumentation and maintenance• Designed various strategies for mutations and strain improvement• Examined sterility and process parameters of fermentation processes• Carried out inoculum development and scale up of fermentation processes• Documentation and maintenance of standard laboratory practices for company records and certifications/audits• Experience with conducting environmental monitoring, sterility testing, antimicrobial susceptibility testing, and bacterial growth kinetic studies• Monitored and developed research protocols• Maintained all study/research records, prepared media, reagents, and buffers according to established procedures

Samir Dave Skills

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

Samir Dave Education Details

  • University Of Mysore
    University Of Mysore
    Microbiology

Frequently Asked Questions about Samir Dave

What company does Samir Dave work for?

Samir Dave works for Fujifilm Diosynth Biotechnologies

What is Samir Dave's role at the current company?

Samir Dave's current role is Associate Director Contamination Control at FUJIFILM Diosynth Biotechnologies.

What is Samir Dave's email address?

Samir Dave's email address is sh****@****ail.com

What is Samir Dave's direct phone number?

Samir Dave's direct phone number is +186077*****

What schools did Samir Dave attend?

Samir Dave attended University Of Mysore.

What skills is Samir Dave known for?

Samir Dave has skills like Microbiology, Biotechnology, Biochemistry, Quality Control, Sop, Validation, V&v, Gmp, Biopharmaceuticals, Project Management, Fda, Molecular Biology.

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