Director, Biologics CMC Technical Writing

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).