Head of Regulatory and Quality, and Senior Consult
United States of America
Tracy TreDenick joined BioTechLogic in 2004 as the Head of Quality and Regulatory. She has over 18 years of experience in Pharmaceutical Quality, Manufacturing and Regulatory. Most recently she has performed multi-product facility audits with additional pre and post viral clearance requirements, global commercialization and submission readiness assessments, and prepared several U.S. and Europe Chemistry, Manufacturing and Control sections in the CTD format for a adjuvanted vaccine, combination product and biosimilar. This responsibility included preparation of documents that spanned the course of process development, clinical and commercial scale manufacturing for both the Drug Substance and Drug Product. This experience enabled a full understanding of the expectations for development, manufacturing and analytical characterization of the product to obtain global product approval. Prior to joining BioTechLogic, Ms. TreDenick directed the validation and pre-approval readiness programs for biopharmaceutical products within Pfizer (formerly Pharmacia Corporation), including the process validation, registration and commercialization of Somavert®, a well characterized recombinant protein product. From 2000 to 2002, Ms. TreDenick was Manager – Global Quality and Compliance for G.D. Searle, a division of Monsanto. During this time she was involved in the quality and regulatory review of women’s health care products. Prior to joining G.D. Searle, Ms. TreDenick had roles with increasing Quality Assurance responsibility for SoloPak Pharmaceuticals and Baxter Health Care that supported drug product Aseptic filling operations. Ms. TreDenick received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She also completed graduate study courses in Business Management at Keller Graduate School of Management.