Remote Associate Director, Small Molecule CMC Ops

Travere Therapeutics; Minneapolis (MN); Sur place; USD 150 000 - 195 000; Plein temps

Résumé du poste

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. This role supports product development, clinical manufacturing, and lifecycle management of small molecule drug products.

You will partner with Quality, Regulatory Affairs, Clinical and Supply Chain to ensure alignment, risk management, and program milestones.

Qualifications

• BS in chemistry, biochemistry, pharmaceutical science, chemical engineering or related field required.
• 8+ years in late-stage clinical development, scale-up, and commercialization.
• Experience managing CDMOs and contract testing labs across global sites.
• Knowledge of cGMP requirements and US/EU/ICH guidelines.
• Experience preparing CMC sections for regulatory filings.

Responsabilités

• Provide technical oversight of API production, scale up, PPQ for small molecule solid oral drug products.
• Review and approve manufacturing documentation, including change notifications and batch records.
• Verify qualification and validation status of CDMOs and external labs.
• Support GMP quality systems, deviations, investigations, CAPAs, and regulatory submissions.
• Collaborate with internal/external teams on CMC development and lifecycle management.
• Prepare and review CMC sections of INDs, IMPDs, and NDAs.
• Maintain knowledge of US/EU GMP requirements and ICH guidelines.
• Oversee project scope, timelines, and deliverables to meet contractual obligations.
• Travel 10–20% domestically and internationally.

Connaissances

CDMO oversight

GMP compliance

Small molecule API

Process development

Regulatory submissions

Cross-functional collaboration

Project management

FDA/ICH guidelines

Technology transfer

Formation

BS in Chemistry/Pharmaceutical Science

MS/PhD preferred

Equivalent education/experience

Description du poste

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Technical Operations (Small Molecule CMC) to provide technical oversight of API development and manufacturing at Travere CDMOs. This role supports product development, clinical manufacturing, and lifecycle management of small molecule drug products.

You will partner with Quality, Regulatory Affairs, Clinical and Supply Chain to ensure alignment, risk management, and program milestones.