Director, Biologics CMC Writing & Submissions

Planet Pharma

San Diego (CA)

Hybrid

USD 189,000 - 246,000

Full time

5 days ago

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Job summary

Travere Therapeutics in San Diego seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead CTD Module 2 and Module 3 authoring for BLA submissions. You will oversee cross-functional teams, develop submission strategies, and deliver regulator-ready narratives that summarize manufacturing, controls, and product characterization.

Ideal candidate has 10+ years in pharma/biotech, strong writing, and extensive biologics experience, including fermentation and downstream

Qualifications

Bachelor’s degree in pharmaceutical sciences or related field; equivalent experience may be considered.
MS/PhD or other advanced degree preferred for seniority.
10+ years of pharmaceutical/biotech experience; CTD Module 2/3 authoring for BLA or equivalent.
Experience with biologics development, fermentation, and downstream processing.

Responsibilities

Lead planning, authoring, and delivery of CMC content for regulatory submissions (BLA).
Coordinate sections including drug substance/product manufacturing, process development, and validation.
Prepare regulator-ready narratives; ensure consistency across Module 3 and alignment with regulatory strategy.
Lead cross-functional forums, resolve technical gaps, manage reviews and approvals.
Prepare governance presentations for regulatory interactions and executive updates.