CMC Strategy Lead, Technical Operations (Remote)

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

Job summary

The role requires overseeing regulatory filings, technology transfer, scale-up, and cGMP compliance, with travel up to 10% domestically and internationally. Based in San Diego, onsite presence is essential.

Qualifications

• Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline.
• 8 years of progressive cGMP related CMC drug development or manufacturing experience.
• Leadership experience in CMC across multiple related areas and drug development with small molecules.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation, and cGMP manufacturing activities across Phase I-III clinical development and commercial products.
• Lead selection, qualification, governance, and performance management of CMOs and external providers to meet scope, quality, timelines and budget.
• Oversee chemical development of new drug candidates.
• Review regulatory filings, specifications, change controls, and Master Batch records.
• Provide technical oversight of CMOs for developing, validating, transferring, and maintaining manufacturing and analytical methods; support regulatory inspections and audits.
• Provide technical leadership and mentorship to colleagues and cross-functional teams.
• Author/edit CMC sections of regulatory submissions as required.
• Additional duties as needed.

Skills

CMC leadership

Small molecule manufacturing

Oral solid dosage

Education

Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline

Job description

The role requires overseeing regulatory filings, technology transfer, scale-up, and cGMP compliance, with travel up to 10% domestically and internationally. Based in San Diego, onsite presence is essential.