Jessica Loduca Blomberg

About Jessica Loduca Blomberg

Jessica brings over 20 years of Chemistry, Manufacturing, and Controls (CMC), Quality, and Regulatory drug development experience. In December 2012, she founded Quality CMC Consulting, LLC, an award-winning pharmaceutical development consulting firm. The company provides global pharma, biotech, and medical device clients innovative solutions that are phase appropriate while applying a balanced interpretation of regulatory expectations and risk. This approach has helped numerous clients succeed in positioning their drug asset for regulatory approval (preIND to market application) and M&A deals amounting to $1.1B deals in 2024 alone. Quality CMC Consulting has worked with almost every drug product type (injectable, oral (liquid & solid), inhaled (solid/liquid), and topical) serving small start-ups to large pharma with a niche in outsourced drug development and novel therapies. Prior to starting Quality CMC Consulting, Jessica worked for small to midsize companies in roles spanning CMC Pharmaceutical Development, Technical Operations, and Quality. While consulting, she has served as the Head of CMC, Head of Quality Unit (QC/QA), and CMC Regulatory across diverse therapeutics areas including rare diseases, oncology, thrombolytics, and vaccine development. She is the co-inventor on multiple CMC formulation patents and provides training to the industry. Jessica was named 2020 Life Science Consultant of the Year by the Triangle Business Journal (TBJ) and 2022 Community Impact leader by the Triangle Leukemia & Lymphoma Society (LLS). She is also an active volunteer in various science groups since 2008 and is currently a Board Member and Program Committee Chair of the Astronaut Scholarship Foundation (ASF) and Board Secretary and Communication Chair for the Parenteral Drug Association (PDA) Southeast Chapter. Jessica holds a Ph.D. in Analytical Chemistry from Duke University and Honors B.S. in Chemistry from University of Central Florida.

Experience

1. Asf Program Committee Chair

   Astronaut Scholarship Foundation

   Dec 2022 — Present · Kennedy Space Center, FL, US

Education

• Duke University

  Doctor of Philosophy (PhD), Analytical Chemistry

• University of Central Florida

  Honors, BS, Chemistry

Skills

• Pharmaceutical Industry
• Sop
• Fda
• Life Sciences
• Clinical Trials
• Standard Operating Procedure (Sop)
• R&D
• Formulation
• Regulatory Requirements
• Ind
• Chromatography
• Hplc
• Regulatory Affairs
• Lifesciences
• 21 Cfr Part 11
• V&V
• Oncology
• Drug Development
• Gcp
• Biopharmaceuticals
• Ctms
• Technology Transfer
• Validation
• Clinical Research
• Capa
• Analytical Chemistry
• Clinical Development
• Change Control
• CRO
• Quality Assurance
• Biotechnology
• Pharmaceutics
• Drug Discovery
• Glp
• Gmp
• Gxp
• Chemistry
• Regulatory Submissions