CMC Strategy Lead, Technical Operations (Remote)

Travere Therapeutics; Boston (MA); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics seeks a Senior Director of Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules through development and commercialization. You will oversee external CMOs, drive technology transfer, and ensure regulatory readiness from Ph I to commercial production.

Join a global team and collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain and Program Management to mitigate CMC risks and achieve milestones while maintaining cGMP

Qualifications

• Strong leadership in CMC activities across development to commercialization.
• Experience with external CMOs and technology transfer.
• Regulatory filings and GMP/compliance expertise.

Responsibilities

• Lead technology transfer, scale-up, validation, and cGMP manufacturing across Ph I-III and commercial products.
• Manage CMOs: selection, qualification, governance, performance vs scope/quality/timelines/budget.
• Oversee chemical development of drug candidates.
• Review regulatory filings, specs, change controls, and Master Batch records.
• Provide oversight of CMOs for APIs/finished dosage forms; support inspections and audits.
• Mentor cross-functional teams; author CMC sections for regulatory submissions.

Skills

CMC Leadership

Tech Transfer

CMO Management

Regulatory Strategy

cGMP Compliance

Project Management

Cross-functional Collaboration

Education

Bachelor's degree in Process or Chemical Engineering

Job description

Travere Therapeutics seeks a Senior Director of Technical Operations to lead the CMC strategy for a diverse portfolio of small molecules through development and commercialization. You will oversee external CMOs, drive technology transfer, and ensure regulatory readiness from Ph I to commercial production.

Join a global team and collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain and Program Management to mitigate CMC risks and achieve milestones while maintaining cGMP