Senior Director Manufacturing and Development
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing novel best-in-class treatments that address some of the biggest unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from cancer or pain.
Pharmaceutical Manufacturing and Development professional with twenty years’ experience solving leadership, technical, and regulatory challenges related to the manufacturing of drug and combination products for early phase R&D, pivotal clinical trials, and commercial distribution. •Manufacturing and Development of Combination Products, Parenteral Injections, Polymers, Emulsions, Small Molecules, Novel Excipients, and APIs •CMO Management •Author of CMC sections for five INDs, two IMPDs, five NDAs, one MAA, one NDS, and multiple supplements •cGMP Formulation, Sterilization, and Aseptic Fill/Finish Expertise •CMC Team Leadership •Commercial and Development Contract Negotiations •SME for FDA Inspections •Budget Analysis / Financial Planning •Packaging and Labeling •Early Supply Chain Management •DHF Management •Due Diligence
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