Director, Biologics CMC Technical Writing
Travere Therapeutics
Director of Technical Operations (Biologics CMC Technical Writing) 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 regulatory interactions High-value specifics: biologics (recombinant proteins, microbial fermentation) drug substance focus late-stage development (BLA) FDA engagement experience international travel (~10%) Location: Remote (San Diego-based, with some onsite requirements). #J-18808-Ljbffr Travere Therapeutics
Vacancy posted 2 days ago
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