Associate Director, Small Molecule CMC Operations (Remote)

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Competitive pay

Bonus opportunities

Retirement plans

Job summary

Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities conducted at Travere CDMOs. This role supports product development, clinical manufacturing, and lifecycle management of small molecule drug products, partnering with Quality, Regulatory Affairs, Clinical, and Supply Chain.

The ideal candidate has 8+ years in late-stage development, with strong experience in process development, characterization,

Qualifications

• BS in chemistry, biochemistry, pharmaceutical science, chemical engineering or related Life Sciences discipline required. MS/PhD preferred.
• 8+ years of relevant experience with emphasis on late-phase clinical development and commercialization.
• Experience managing CDMOs and contract testing labs across global sites and knowledge of cGMPs.

Responsibilities

• Provide technical oversight of API production, scale-up, process characterization, and PPQ for small molecule drug product.
• Review and approve manufacturing documentation including batch records, development, tech transfer, validation reports.
• Ensure CDMO qualification, validation status, and regulatory alignment for GMP processes.
• Support GMP quality systems, deviations, CAPAs, change controls, and regulatory submissions.
• Collaborate with project teams on CMC development, clinical supply, and lifecycle management.
• Prepare and review CMC sections of INDs, IMPDs, and NDAs.

Skills

API development

CDMO oversight

Regulatory submissions

GMP knowledge

Education

BS in chemistry/biochem

MS/PhD preferred

Job description

Travere Therapeutics is seeking an Associate Director, Technical Operations (Small Molecule CMC) to oversee API development and manufacturing activities conducted at Travere CDMOs. This role supports product development, clinical manufacturing, and lifecycle management of small molecule drug products, partnering with Quality, Regulatory Affairs, Clinical, and Supply Chain.

The ideal candidate has 8+ years in late-stage development, with strong experience in process development, characterization,