Provide expert CMC, Operations, Manufacturing and CRO/CDMO contracting and management expertise in support of the overall mission of Kinexum of providing Translational and Strategic Services to clients in order to progress new pharmaceutical products from the research phase into early development/proof of concept, full development and eventual commercialization and life cycle management.

Provider of strategic and tactical Pharmaceutical Product Development consulting for preclinical, clinical, registration and commercialization projects for domestic and international clients.

Lead the company’s Combination Drug/Device new product development function employing its proprietary auto-injector technology for both sterile needle-less and pre-filled syringe technologies. Provided technical support of commercial product line and led corporate level Quality Assurance across two sites. Accountable for Formulation Development, Analytical Development, Process Development, Program Management and Quality Assurance for 505(b)2 and ANDA regulatory filings and approvals. Work with Business Development in securing 3rd party licensing of Antares' proprietary technologies.

Recruited by the founders of the company to improve execution of day-to-day business operations, assist in clarifying business strategy and improve productivity of new business development activities.

As COO, led the day-to-day operations of the company allowing the CEO to focus on raising capital. Principal technical lead on partnering and in/out-licensing discussions. Led the Development team progressing new product pipeline for drug/device combination products along aggressive timelines; successfully developing and gaining FDA approval of the lead product (drug/device combination) 505(b)2 NDA in approximately 2 years from initiation of the project.

As the second hire, was a key player in establishing a new Business Unit offering product development and commercialization services to the Pharmaceutical (OTC, Nutritional and Rx) and Medical Device industries. Responsible for building the business from a zero basis to $40MM annual revenue, a customer base of more than 50 clients and over 300 employees at two sites in the US and UK. Successful in applying Cardinal’s proprietary technologies as solutions to customers’ problems for OTC, NDA and ANDA projects for products available commercially today. Sole Business Development lead during initial start-up phase – eventually provided leadership to Business Development staff supporting the site. Identified and led licensing of a proprietary solid dose form technology from external source. Participated in numerous acquisition activities including identification of internal technology solution gaps to be filled, identification of potential targets and eventual due diligence.

Led the development activities for the small molecule Pharmaceuticals and the Drug Delivery Divisions. This included oral, surgical implants and sterile hydrogel based injectable projects.

Scope of responsibility included providing Pharmaceutical Development technical input and support for moving compounds out of Research into first-time-in-man studies, new product development and interfacing with commercial Manufacturing assisting in resolution of production issues. Contributed to 8 NDA’s and numerous IND’s developed for Oral, Sterile, Topical, Transdermal and polymer based Controlled Release dosage forms for both human and veterinary pharmaceutical divisions. Participated on numerous due diligence teams assessing in-licensing opportunities.

Part of team which took a new product development project assignment from bench to eventual NDA approval. This product is still on the market today.