Highly-accomplished formulation scientist with a solid reputation for innovation, research management, and CMC team leadership. Extensive knowledge of pharmaceutical formulation, drug delivery, device development, analytical and synthetic chemistry, sterilization processes, ICH guidelines, and FDA regulations. Experienced in collaborating and coordinating projects with Marketing, Pilot Plants, PK, Toxicology, Analytical Chemistry, Packaging, Manufacturing and other Functions. Highly experienced in ophthalmic drug delivery, with technology that is readily applicable to other modes of administration [e.g., otic, intravenous, subdermal]. Globally-recognized Ph.D. with 50+ U.S. and international patents/patent applications, 55+ published papers, and a solid network of contacts within the scientific community. Expertise in applying QbD. I am currently affiliated with Atheln Inc, which "specializes in the creation of product and commercial strategies."

Directed scientists in the innovation, preparation, and exploratory research of novel drug delivery formulations/devices with proteins, polypeptides, and LMW drugs for ophthalmic use. Group investigated sterile/aseptic biodegradable formulations including microspheres, implants, injectable depots, and suspensions for intravitreal, intracameral, and topical administration. Several technologies had non-ophthalmic applications and were successfully transferred to Allergan’s Dermatology Drug Delivery Group and the Aesthetics area. Served as a CMC Team Leader and a Clinical and Core Team member.

Innovated, planned, directed, and produced novel ophthalmic and otic drug formulations and devices for sustained and controlled release products; managed a $1.52 million-dollar budget. Recruited 6-8 scientists; trained managed, and mentored 13 individuals with differing scientific background [physics, drug delivery, pharmaceutics, analytical chemistry, biochemistry and engineering]. Actively participated in monthly meetings with Marketing, co-planning five-year ophthalmic product development and directing Drug Delivery Group to meet the approved plan. Wrote the pharmaceutics CMC sections of INDs and NDAs and contributed to regulatory responses.