Director, Biologics CMC Technical Writing

Role: Director of Technical Operations (Biologics CMC Technical Writing) leading the preparation of CMC documentation for regulatory submissions such as BLAs, with a focus on biologics drug substance development. Responsibilities: develop and execute CMC submission strategies; author and coordinate Module 3 content covering manufacturing processes, characterization, validation, stability, and lifecycle changes; ensure regulatory compliance and content consistency; lead cross-functional teams and manage external partnerships; support regulatory interactions, including responses to FDA requests; establish best practices in CMC writing. Requirements: Bachelor’s in pharmaceutical sciences, chemical engineering, biotechnology, or related field; 10+ years in pharma/biotech, with expertise in biologics manufacturing and development, particularly microbial fermentation and recombinant proteins; experience authoring CTD Module 2/3 for biologics BLA or similar. Preferred: MS or Ph.D., experience with lyophilized products, combination devices, and regulatory interactions. High-value specifics: biologics (recombinant proteins, microbial fermentation), drug substance focus, late-stage development (BLA), FDA engagement experience, and international travel (~10%). Location: Remote (San Diego-based, with some onsite requirements).