Tracy TreDenick

Tracy has over 28 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 an adjuvanted vaccine, combination product, and biosimilar. This responsibility included the 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.

Ms. TreDenick previously 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.

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