ROBBI FREISEM

Robbi Freisem
Director, Quality Assurance

Robbie has more than 25 years of experience in the pharmaceutical industry including small molecule, well-characterized biologics and biological vaccines. Robbi has hands-on experience in biological vaccine development and purification, aseptic processing, dosage form development, lyophilization, tableting and coating, and aseptic filling and packaging. She has had quality assurance responsibility for process tech transfer of formulation, aseptic filling operations, packaging and finish for commercial supply, and commercial launch from multiple contractors. Recent responsibilities include establishing and directing Quality Assurance for a small molecule development company in Phase III clinical trials. Her extensive development experience has provided the understanding to practically apply implementation of regulations for GXPs and quality systems and to ensure compliance with all major regulatory bodies. Robbi has held positions of increasing responsibility at Wyeth-Ayerst, Centocor, Inc. and Cardiokine, Inc. She received a BS in Biology from Grove City College and completed graduate work at the University of Michigan.

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