Michael Carroll

Senior Consultant, Microbiologist


Mr. Carroll is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries. He is experienced in all phases of development, PAI, regulatory approval and product launch. He provides experimental analyses and applies knowledge to resolve quality issues.

Mr. Carroll provides technical guidance reviewing analytical methodology, assuring compliance with regulatory GMP guidelines, and initiating Quality Control laboratory process improvements.

  • Developing scale-up, environmental and maintenance monitoring programs,
  • Created accurate low-cost LAL test: Firm was using an unreliable LAL test on a lipid-containing product. Created and validated a new LAL test with higher accuracy rate and virtually no false positives. Reduced lot turnaround times and decreased costs 60%,
  • Oversaw validation and implementation of new test globally. Firm needed 'Harmonized' Compendial Microbial Limits test validated and implemented in 140+ sites,
  • Managed multiple (8) successful aseptic processing facility start-ups,
  • Developing and validating microbiological test methods and specifications,
  • Designing, qualifying and implementing new products/processes.

Mr. Carroll earned a BS in Biology/Pre-Med from the University of California at San Diego and a Medical Technology certification from Pennsylvania Hospital. He is ASCP Certified and a member of the Parenteral Drug Association (PDA).

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Core Competencies

  • Aseptic Production
  • Sterilization
  • Dehydrogenation
  • Process Validation
  • Analytical Validation
  • Biologics
  • Medical Device
  • Monitoring Programs
  • Product Launch