I apply compendial standards (USP, EP, BP, FCC, JP) to raw material testing and release programs, and help structure vendor, CMO, and CRO oversight.
I oversaw incoming raw materials, excipients, packaging materials, and media for large-molecule biologics, managing CMC responsibilities in alignment with supply chain and the material management system. I also worked with CROs on the development and validation of DNA, kanamycin, glycine, cyanide, and clearance studies.
I set up and streamlined vendor management and contract testing laboratories, audited vendors, suppliers, and testing laboratories, and reviewed and approved quality and service agreements with CROs and CMOs.
I initiated a vendor qualification program, put vendor quality and service agreements in place to be cGMP compliant, and developed a strategy to ensure access to the CRO analytical capabilities and capacity needed to support product and API development.
I work with pharma and biopharma organizations on monograph and reference-standard development, and my background includes involvement in compendial harmonization across USP, EP, and other pharmacopeias.
Incoming material quality you can rely on, with less rework downstream.