Director, Biologics CMC Technical Writing

Role: Director of Biologics CMC Technical Writing, leading preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions like BLA. Objectives include developing strategic content for biologics, especially drug substance processes, ensuring regulatory readiness, and managing cross-functional collaborations. Responsibilities encompass authoring and coordinating Module 3 sections, translating technical data into clear narratives, developing document strategies, and supporting responses during review; overseeing document reviews and approval workflows; and collaborating with internal teams and external partners. Requirements include a Bachelor’s in pharmaceutical sciences, chemical engineering, or biotech with 10+ years' industry experience; expert in biologics development, manufacturing, analytical control, and related areas; extensive experience authoring regulatory CMC content for biologics submissions, particularly modules 2 and 3; strong scientific judgment, communication, and leadership skills. Preferred qualifications include advanced degrees (M.S./Ph.D.), experience with microbial fermentation, lyophilized drug products, combination products, and device-related activities; experience with FDA interactions, regulatory responses, and delivering presentations at high levels. High-value specifics: biologics, recombinant proteins, microbial fermentation, late-stage biologics, regulatory submission strategy, and cross-functional leadership. Work setup includes remote work with approximately 10% domestic and international travel.