Virginia (Kit) Goldman Email & Phone Number

Experienced project leader, product developer and laboratory scientist with extensive industry background in Research & Development and launch of over-the-counter topical products, medical devices and combination products. Effective collaboration with Manufacturing, Quality Assurance, Regulatory, and Marketing departments has led to establishment of appropriate product specifications, efficient manufacturing processes and successful regulatory strategies. Have developed medical device specifications under Quality System Regulations (QSR) based on marketing input, generated technical data and compiled required documentation for medical device 510(k) applications. Experienced in technology evaluation from scientific due diligence to manufacturability. Acknowledged leadership and supervisory skills (junior and senior scientists), coupled with technical expertise and ability to both work with and lead teams, have been utilized to make significant contributions to marketed products. Doctoral and post-doctoral training in plant biochemistry and physiology, with wide-ranging knowledge of chemoreceptors, wound healing and plant-derived products (botanicals). Co-holder of patents related to antimicrobials and biochemical pathways related to receptors.Specialties: OTC topical product and medical device development. Collaboration with internal and external colleagues and teams.

Listed skills include Technology Transfer, Pharmaceutical Industry, Medical Devices, Fda, and 18 others.