Dr. Jessica Blomberg, Founder and CEO of Quality CMC Consulting, is an industry leader in Chemistry, Manufacturing & Controls (CMC), regulatory strategy, and quality systems, with nearly 25 years of experience helping biopharma, biotech, and cell and gene therapy companies navigate drug development, regulatory approvals, and partnerships. She has spent over 12 years advising companies on CMC strategy, outsourcing, and risk mitigation to accelerate successful drug programs. With expertise spanning injectables, solid & liquid oral, inhalation, and topicals, she has played key roles in advancing novel therapies from early development through clinical trials and commercialization. Her recent achievements include designing QC Strategies for the first spin-outs from Nobel Laureate David Baker’s Institute for Protein Design, ensuring a strong regulatory foundation for cutting-edge biologics. She has supported start-ups in laying the first board for platform technologies, helping them build scalable drug pipelines and in selecting the right contract development and manufacturing organizations (CDMOs). Additionally, she has led the regulatory and technical repositioning of commercial-stage assets from the EU to the U.S., navigating complex partnerships and regulatory challenges. She helps companies transition from proof-of-concept to IND, scale-up, and commercialization, structuring CMC strategies that position them for M&A, licensing, or sustainable supply chains. She has served as an acting/interim Head of CMC, Technical Operations, QC, and QA, ensuring partnerships succeed beyond the contract. A co-inventor on multiple formulation patents, Dr. Blomberg has been an active leader in AAPS and PDA since 2008. She serves as Board Member and Program Committee Chair for the Astronaut Scholarship Foundation, a national STEM scholarship program awarding over $1-million annually. She was also an instructor at the 2024 Triangle University Startup Bootcamp, mentoring biotech entrepreneurs. Recognized for advancing NC’s life sciences industry, she was honored as the Triangle Business Journal’s 2020 Life Science Consultant of the Year.