A Consultant with over 15 years of experience in the outsourcing business model for Operations and Quality.
Her niche is helping clients with Chemistry, Manufacturing and Controls (CMC) related activities at Contract Manufacturing Organizations (CMOs) from pre-IND to commercial stages supporting small molecule and biologic programs.
Jessica has a broad background and in depth understanding of the outsourced drug development paradigm, from discovery to commercial for both small molecule and biologic programs. Her CMC experience includes Operations (project management, formulation and testing development, manufacturing, and supply chain) and Quality (QA/QC), specializing in the outsourced CMC business model.
Jessica has a Ph.D. in Analytical Chemistry from Duke University and a Honors B.S. in Chemistry from the University of Central Florida. She resides in Raleigh, North Carolina and has conducted business with CMOs in the USA, Canada, UK, and EU.
Examples of projects completed:
Served as the Client’s Quality (QA/QC) representative to bring a lyophilized biologic product back on the US market. This involved due diligence audits, vendor selection, formulation development support, process and method development, process and method validation, comparability exercises, and Pre-Approval Inspection (PAI) activities for both the drug substance CMO and the drug product CMOs, all of which were in the EU.
Acted as a Quality or a 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 a primary author for client study design protocols, reports, and regulatory submissions including INDs, BLAs, NDAs, DMFs, and Annual Reports.
Authored and executed Quality Agreements for Phase 1 to Commercial programs at intermediate, drug substance, and drug product CMOs.
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.
Worked with a Non-Profit and Government Organization for a Phase IV trial by providing vendor selection, project management support, and Quality support.
Worked with a commercial-focused client to perform a gap analysis of their SOP system to support clinical trial release.