Assisting life-science firms achieve excellence in Quality, speed, and Regulatory compliance in work of developing, manufacturing, and outsourcing biologics, drugs and devices including selecting, auditing and managing vendors.

For drugs and biologics and their APIs, lead process development, scale-up, & transfer to CMOs; oversee troubleshooting, validation, and commercial manufacture. Support registration, including authoring technical sections of FDA filings and negotiating with Regulators. Perform due diligence for M&A opportunities resulting in $1.9B investments with $1.7B milestones.

In R&D improved manufacturing processes for large-scale industrial chemicals.
In the Engineering Department had personal responsibility for overseeing CMOs developing and manufacturing protein therapeutic & delivery devices and authoring technical sections of Regulatory filings. As Sr. Project Engineer, served on team managing construction of new manufacturing facility with special responsibility for personnel and material transfer to/from the sterile core.
Led Pharmaceutical Development department, creating small- and large-molecule drugs. As Preclinical Director led development, including management of small-/large-animal vivarium. Headed Corporate Quality Assurance as interim; addressed quality culture and resolved manufacturing quality issues at our European plant, returning 9 products from “stop sale” status