Spore.Bio Appoints Dr. Michael J. Miller as VP of Scientific & Regulatory Affairs to Advance Rapid Microbiology in Manufacturing Quality Control

Spore.Bio, a company at the intersection of AI, biophotonics, and microbiology, today announced that renowned microbiologist, Dr. Michael J. Miller has joined as Vice President of Scientific & Regulatory Affairs. His appointment marks yet another step in Spore.Bio’s mission to embed rapid, modern microbiology at the heart of pharmaceutical manufacturing and other highly regulated industries worldwide. 

With nearly 40 years of experience in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods, Dr Miller has held senior and executive roles in Microbiology at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb. 

He has served as an expert witness on numerous pharmaceutical and medical device patent and product liability cases, has advised the USP Microbiology Expert Committee, authored more than 100 technical publications and presentations, and serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review, and the PDA Journal of Pharmaceutical Science and Technology. Through his consultancy, he now advises multinational companies on microbiology, quality, and regulatory affairs. 

He is also chairperson for the revision of PDA Technical Report No. 33 - created to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test - and provides an educational platform dedicated to the advancement of rapid microbiological methods through Rapid Microbiological Methods. At Spore.bio he will combine this experience and his regulatory skills and expertise to further strengthen the company's strategy as it scales.

“Bringing the biggest Key Opinion Leader of our field into Spore.Bio is a strong signal of where we’re headed as a company,” said Amine Raji, CEO, Spore.Bio. “His decades of experience in rapid methods, contamination control, and regulatory strategy give us exactly the kind of scientific and regulatory backbone we need as we scale and with Michael on board, we’re not just advancing our technology – we’re raising the bar for how it is validated, implemented and communicated to regulators, partners and customers. This is an important milestone for Spore.Bio, and it’s only the beginning of what we’ll be announcing in the weeks ahead.”

“Spore.Bio is tackling a problem I’ve spent my entire career thinking about: how to make microbiology faster, more reliable, and more actionable for manufacturers,” said Dr. Michael J. Miller, VP of Scientific & Regulatory Affairs at Spore.Bio. “The combination of AI, biophotonics, and microbiology Spore.Bio is building has the potential to redefine what ‘rapid methods’ mean. I’m excited to work with a firm that continues to set the standard for what a scientifically robust, validated and regulated platform can bring to users across pharma and beyond.”