Jessica Blomberg, Ph.D., is Founder and CEO of Quality CMC Consulting, an industry leader specializing in Chemistry, Manufacturing & Controls (CMC), regulatory strategy, and quality systems. With nearly 25 years of experience, she guides biopharma, biotech, and cell and gene therapy companies through drug development, regulatory approvals, and product lifecycle management. Her expertise spans injectables, solid and liquid oral formulations, inhalation, and topical therapies with a niche in novel therapies.

Throughout her career, Dr. Blomberg has advanced innovative therapies from early development through commercialization, notably designing quality control strategies for pioneering spin-outs from Nobel Laureate David Baker’s Institute for Protein Design. This leadership has contributed to numerous regulatory approvals and over $1.1 billion in biotech mergers and acquisitions in 2024 alone.

Active in professional organizations since 2008, she has held leadership positions with the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA). Committed to nurturing the next generation of STEM leaders, she currently serves as Board Member and Program Committee Chair for the Astronaut Scholarship Foundation, mentoring scholars and supporting university entrepreneurship. Recognized for her contributions, she was honored as the Triangle Business Journal’s 2020 Life Science Consultant of the Year and continues to champion innovation within the life sciences community.

Jessica received the Astronaut Scholarship (then Mercury Seven Scholarship) in 1996-98 at UCF where she received an Honors B.S in Chemistry. She received her Ph.D. in Analytical Chemistry from Duke University in 2003. Jessica is the co-inventor of multiple patents and provides training to the industry.