Director, Biologics CMC Technical Writing

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.

• authoring and coordinating Module 3 sections
• translating technical data into clear narratives
• developing document strategies
• supporting responses during review
• overseeing document reviews and approval workflows
• collaborating with internal teams and external partners

• 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

• advanced degrees (M.S./Ph.D.)
• experience with microbial fermentation
• experience with lyophilized drug products
• experience with combination products
• experience with device-related activities
• experience with FDA interactions, regulatory responses, and delivering presentations at high levels.

• biologics
• recombinant proteins
• microbial fermentation
• late-stage biologics
• regulatory submission strategy
• cross-functional leadership

Work setup includes remote work with approximately 10% domestic and international travel.