CMC Strategy Lead, Technical Operations

Travere Therapeutics; Wichita (KS); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health coverage

Well-being programs

Life insurance

Disability coverage

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking a Senior Director of Technical Operations to lead the CMC strategy across a diverse portfolio. You will manage external manufacturing partners, ensure timely development and manufacturing readiness, and collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to mitigate CMC risks.

The role requires extensive cGMP experience, leadership across multiple CMC areas, and the ability to navigate regulatory submissions.

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, with drug development experience in small molecules (oral and injectable) and possibly peptides/biologics.

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 the selection, qualification, governance, and performance management of CMOs, collaboration partners, and other external technical service providers, ensuring delivery against agreed 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 responsible for developing, validating, transferring, and maintaining manufacturing and analytical methods for clinical and commercial production of APIs and finished dosage forms. Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP requirements and global regulatory expectations.
• Provide technical leadership and mentorship to colleagues and cross-functional project teams.
• Author/edit CMC sections of regulatory submissions as required
• Additional duties assigned as needed.

Skills

CMC leadership

Communication skills

Team collaboration

Oral solid dosage forms knowledge

Education

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

Tools

Regulatory filings tools

Job description

Travere Therapeutics is seeking a Senior Director of Technical Operations to lead the CMC strategy across a diverse portfolio. You will manage external manufacturing partners, ensure timely development and manufacturing readiness, and collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain to mitigate CMC risks.

The role requires extensive cGMP experience, leadership across multiple CMC areas, and the ability to navigate regulatory submissions.