CMC Strategy Lead, Technical Operations (Remote)

Travere Therapeutics; Atlanta (GA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Work-life programs

Well-being offerings

Life insurance

Disability insurance

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Director of Technical Operations to oversee the development, execution, and ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development. You will manage external manufacturing partners and collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and hit milestones.

The role requires leadership across Phase I-III and commercial products, with deep knowledge of

Qualifications

• Bachelor's degree in a relevant field is required.
• 8+ years of progressive cGMP related CMC drug development or manufacturing experience.
• Demonstrated leadership in CMC across multiple areas and small molecules/biologics experience.

Responsibilities

• Provide strategic and technical leadership for technology transfer, scale-up, validation and cGMP manufacturing across Phase I-III and commercial products.
• Lead selection, qualification, governance and performance management of CMOs and external providers.
• Oversee chemical development of new drug candidates.
• Review regulatory filings, specifications, change controls and Master Batch records.
• Provide technical oversight of CMOs for development, transfer and maintenance of APIs and finished dosage forms; support inspections.
• 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

Leadership

Strategic thinking

Cross-functional collaboration

Project management

Communication

Education

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

Job description

Travere Therapeutics is seeking a Senior Director of Technical Operations to oversee the development, execution, and ongoing oversight of the CMC strategy for a diverse portfolio of small molecules in development. You will manage external manufacturing partners and collaborate with Quality, Regulatory Affairs, Clinical, Supply Chain, and Program Management to mitigate CMC risks and hit milestones.

The role requires leadership across Phase I-III and commercial products, with deep knowledge of