Director, Biologics CMC Technical Writing

Scorpion Therapeutics; California (MO); Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead regulatory writing for biologics. You will develop submission strategies, author Module 3 content, and coordinate cross-functional teams including external partners. Remote role with some onsite requirements in San Diego; international travel ~10% may apply.

Ten-plus years in pharma/biotech with biologics expertise is expected. Ideal candidates hold a Ph.D.

Qualifications

• Bachelor’s in pharmaceutical sciences, chemical engineering, biotechnology, or related field.
• 10+ years in pharma/biotech with expertise in biologics manufacturing and development (microbial fermentation and recombinant proteins).
• Experience authoring CTD Module 2/3 for biologics BLA or similar.

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.

Skills

Biologics manufacturing

Regulatory writing

CTD Module 2/3

FDA interactions

Cross-functional leadership

Regulatory strategy

External partnerships

Lyophilized products

Combination devices

Life sciences

Education

Bachelor’s in pharmaceutical sciences/related

MS or Ph.D.

Job description

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).