Responsible for leading and managing departments supporting CMC/Tech Ops functions including process development, analytical development, manufacturing and supply chain.

Responsible for leading and executing all CMC functions including process development, analytical development, manufacturing, supply chain, IND authoring, budgeting and strategy for a viral vector based gene therapy to treat a rare disease.

Responsible for leading External Manufacturing department and oversight of CMO network which manufactures plasmid DNA, mRNA, gene therapy viral vectors and cell therapy products for clinical trial use. CMC leader for 2 of the companies partnered programs.

Responsible for CMO lifecycle management of several commercial biologics including Activase, Herceptin and Rituxan. Activities included CMO selection, contract negotiations, technology transfer, PPQ campaign execution, regulatory submission, PAI / licensure, commercial GMP mfg, post marketing commitments and budget management up to $100M/year. Technical Product Leader for Perjeta. Experience working with several CMOs including Lonza, Boehringer Ingelhiem and Samsung Biologics.

Responsible for leading CMC project management group in support of mfg projects, contract mfg, validation and compliance.

Mfg lead on new BioNext project (9 x 20,000L scale facility) for Enbrel and responsible for user requirements and mfg input into design of the facility. Responsible for reviewing documents from conceptual design through detailed design, P&IDs, 3D CAD, process modeling, GMP equipment selection and FAT.

Performed CHO cell line selection and development of Humira cell culture process. Supported plant start-up of cell culture operations. Executed tech transfer into mfg and transitioned into mfg role to lead Phase 1 GMP mfg of Humira drug substance. Primary contact for managing in-sourced GMP mfg projects from other companies.