Associate Director, Drug Product Operations (Remote)

Travere Therapeutics; United States; Hybrid; USD 150,000 - 195,000; Full time

Job summary

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

The role requires deep expertise in amorphous solid dispersions, PPQ, and regulatory filings (INDs/IMPDs/NDAs), plus the ability

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related field."
• Advanced degree preferred (MS/PhD) in Chemical/Biochemical disciplines.

Responsibilities

• Oversee drug product manufacture scale-up and PPQ at Travere's CDMOs.
• Review manufacturing documents: change notifications, batch records, tech transfer, validation protocols.
• Qualify CDMOs and external labs for compliance and quality.
• Support GMP quality systems: deviations, investigations, CAPAs, change controls.
• Collaborate on CMC development and commercialization with internal/external teams.
• Prepare and review INDs, IMPDs, and NDAs.
• Maintain knowledge of US/EU cGMPs and regulatory guidelines.
• Manage CDMO scope, contracts, and timelines.
• Advise leadership on CDMO performance and risk.

Skills

CDMO management

Regulatory filings

Process development

GMP knowledge

Scale-up

Small molecule manufacturing

Education

Bachelor in Chemistry/Pharmaceutical Sciences

Advanced degree preferred (MS/PhD)

Job description

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

The role requires deep expertise in amorphous solid dispersions, PPQ, and regulatory filings (INDs/IMPDs/NDAs), plus the ability