Remote Director, Biologics CMC Technical Writing
Scorpion Therapeutics
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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
Education
Job description
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.
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