Biopharm Forge (BF) accelerates the next funding round for clinical-stage biopharmaceutical companies by establishing stage-appropriate Quality Systems, by organizing documentation and filling gaps for potential investors, and by assisting in making good Operations decisions. For established companies BF advises on and assists in the broad range of Quality and CMC activities for APIs, drugs, biologics, & devices, performs CSV and GxP audits and conducts due diligence for partnering and acquisition.

Perform Quality Assessments of procedures for development of medical devices by the School of Medicine's Institute for Global Health. Address compliance with US and international regulatory requirements.

Head of Quality function and key team member formulating strategy with the 3 founders of this early-stage company developing orthopedic implants with break-through technology (prototypes and initial ex-vivo testing completed).

.. After joining Cephalon as Associate Director at the launch of our first product, my responsibilities continued to grow and focused in two areas: (1) senior leadership in manufacturing and process development, initially entirely with external contract partners(2) performing due diligence to support our strategic initiative to grow by acquisition of late-stage biotech and small molecule products. My key roles have been to establish procedures, to develop existing staff and to add personnel to ensure the continuing swift and successful evaluation, process development, technical transfer, registration, validation and commercial production of drug substances and products. I oversaw and participated in all aspects of this work, in due-diligence assessment of acquisitions, in selection of manufacturing and packaging partners, in transfer and validation of analytical methods, in facility audits, in negotiation of Quality Agreements, and in preparation of Module 3 of regulatory filings and the negotiations with regulatory authorities in the US and Europe. In addition one of my subordinates and I authored a complete sNDA detailing manufacturing changes which received FDA approval.