Eric Jacobson

Responsible for generating Chemistry, Manufacturing, and Controls (CMC) source documents for all regulatory applications as well as collaborating with various internal/external partners in, authoring, reviewing, finalizing, and assembling various sections of CMC and regulatory documents.

Developed, wrote, and edited CMC-related technical data for inclusion in Module 3 of the common technical document (CTD) for cell therapy products. Activities extended to overseeing information from standard operating procedures (SOPs), batch records, stability protocols, manufacturing process development, validation reports, etc. for the preparation of INDs and IND amendments.

Provided regulatory writing, regulatory intelligence, and technical due diligence capabilities. Activities included: writing documents per regulatory authority guidelines and requirements and client specifications, leading and participating in project-related meetings and teleconferences, acting as a client point of contact, advising on chemistry manufacturing and control, researching and communicating technical details.

Consultant, through Oxford Regulatory and Compliance, on the redesign and reformulation of vaccine processes. Providing support and guidance in: Technical writing of protocols and reports, project management, writing technical summaries of studies for Phase II clinical trials, data extraction and analysis, and process development activities.

Contract worker through the Astrix Technology Group, at Nitto Denko Avecia, a company specializing in the cGMP manufacture of custom oligonucleotides. Completed a project which supported a cGMP oligonucleotide process development/validation program that was producing an oligonucleotide for use as an adjuvant in an anthrax vaccine.

Facilitated and guided: formulation production and analysis, project management, handling external collaborations, working with cGMP contractors to scale-up pilot formulations, designing experiments to assess vaccine efficacy, supervising staff, writing grants, data presentation and analysis, preparation of reports, writing SOP’s, conducting literature reviews, identification of key opinion leaders, overseeing equipment calibration, and ensuring compliance with regulations.