Founder & Ceo
CurrentQuality CMC Consulting helps pharma/biotech/medical device clients with virtual CMC related activities at outsourced vendors from pre-IND to commercial stages. Experienced in CMC Operations (PM, formulation & testing development, manufacturing, supply chain, and regulatory) and Quality (QC/QA). Examples of projects completed:• Acted as a Quality/CMC representative on small molecule and biologic projects at different stages in development (pre-IND to commercial) for intermediates, drug substances, and various drug product forms such as: lyophilized injectable (biologic), liquid injectable (small molecule), ophthalmic injectable (small molecule), oral solids & liquids (small molecule), and semi-solid (small molecule). • Served as the Client’s Quality representative to bring a lyophilized biologic product back on the US market. This involved due diligence audits, vendor selection, formulation development, process and method development, process and method validation, comparability exercises, and Pre-Approval Inspection activities at both the drug substance and the drug product CMOs, all of which were in the EU. The cardiac drug received FDA approval in 2017. • Served as a primary author for client reports and regulatory submissions: INDs, BLAs, NDAs, DMFs, and Annual Reports.• Authored and executed Quality Agreements for Phase 1 to Commercial programs.• Served as the SME to a multibillion dollar, global company on a marketing research project with the goal to investigate how to best optimize an outsourced CMC business offering.• Worked with start-ups to optimize their CMC development plans and vendor selection to aid in fundraising activities. • Provided vendor selection, PM, and Quality support for a Non-Profit and Government Organization (Phase IV)• Performed a gap analysis on a client's commercial SOP system to support clinical development.• Built a Quality Management System • Conducted audits: due diligence, re-qualification, and PAI support.
