Associate Director, Drug Product Operations (Remote)

Travere Therapeutics; San Diego (CA); Híbrido; USD 150.000 - 195.000; Jornada completa

Descripción de la vacante

Travere Therapeutics in San Diego seeks an Associate Director, Technical Operations– Drug Product to lead manufacturing scale-up, validation, and commercialization of small molecule solid oral products. You will manage external CDMOs and collaborate across Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.

This role requires 8+ years in small molecule drug product manufacturing, expertise in amorphous solid dispersions, and experience with regulatory filings (INDs/NDAs).

Formación

• 8+ years in small molecule drug product manufacturing with focus on scale-up, late-phase development, and commercialization.
• Experience with amorphous solid dispersions and solid oral dosage forms.
• Experience managing global CDMOs and external labs.
• Strong knowledge of cGMP, US/EU/ICH guidelines.
• Experience preparing CMC modules for INDs/NDAs.

Responsabilidades

• Oversee production scale-up, process characterization, and PPQ at CDMOs for solid oral products.
• Review manufacturing docs, batch records, and change controls for compliance.
• Validate and qualify processes at CDMOs and external labs.
• Provide GMP quality system support including deviations, investigations, CAPAs, and regulatory submissions.
• Collaborate on CMC development and commercialization with internal and external teams.
• Prepare regulatory filings and ensure documentation meets IND/IMPD/NDAs requirements.
• Stay updated on GMP guidance and regulatory expectations.
• Manage CDMO performance, risk, and project timelines; travel 10–20%.

Descripción del empleo

Travere Therapeutics in San Diego seeks an Associate Director, Technical Operations– Drug Product to lead manufacturing scale-up, validation, and commercialization of small molecule solid oral products. You will manage external CDMOs and collaborate across Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain.

This role requires 8+ years in small molecule drug product manufacturing, expertise in amorphous solid dispersions, and experience with regulatory filings (INDs/NDAs).