Senior biotech professional with over 20 years experience developing recombinant DNA proteins, monoclonal antibodies and stem cells for use in the development of clinical therapies. Extensive experience with all phases of clinical protein expression, development and scale-up with special concentration in the shepherding of promising clinical therapies through the rigorous scrutiny of regulatory FDA processes and approvals. This experience includes creating cell lines, creating and/or stabilizing the manufacturing process, auditing facilities, documenting SOPs and Batch records, reviewing and approving SOPs and Batch records, training personnel and working closely with the Quality, Regulatory and Clinical departments to ensure FDA approval.
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