Remote CMC Operations Lead – Tech Transfer & Compliance

Travere Therapeutics; San Diego (CA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Stock option plan

Generous time off

Job summary

Travere Therapeutics is seeking a senior-level professional to lead the CMC strategy for a diverse portfolio of small molecules in development. The role ensures test article and study drug are developed and manufactured on time, within budget and scope, guiding external manufacturing partners and collaborating with Quality, Regulatory, Clinical, Supply Chain and Program Management.

The ideal candidate will drive technology transfer, scale-up, validation and cGMP activities across clinical and

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 areas and drug development stages.

Responsibilities

• Provide strategic leadership for technology transfer, scale-up, validation, and cGMP manufacturing across I-III and commercial products.
• Oversee selection and governance of CMOs and external partners to meet scope, quality, timelines and budget.
• Lead chemical development of new drug candidates and review regulatory filings and master batch records.
• Provide technical oversight of CMOs for developing and maintaining manufacturing and analytical methods for APIs and finished dosage forms.

Skills

Tech transfer

Scale-up

cGMP

Risk management

Leadership

Regulatory knowledge

Education

Bachelors in Chemical Engineering

Tools

CMO management

Job description

Travere Therapeutics is seeking a senior-level professional to lead the CMC strategy for a diverse portfolio of small molecules in development. The role ensures test article and study drug are developed and manufactured on time, within budget and scope, guiding external manufacturing partners and collaborating with Quality, Regulatory, Clinical, Supply Chain and Program Management.

The ideal candidate will drive technology transfer, scale-up, validation and cGMP activities across clinical and