Travere Therapeutics logo
Travere Therapeutics

In rare for life.

Associate Director, Technical Operations – CMC Strategy

OperationsOperationsFull TimeRemoteSeniorTeam 201-500Since 2013H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

1 day ago

Salary

$150K - $195K / year

Seniority

Senior

Bachelor Degree8 yrs expExperience acceptedEnglish

Job Description

Associate Director, Technical Operations – CMC Strategy

Travere Therapeutics

• Provide strategic and technical leadership for technology transfer, scale-up, and cGMP manufacturing activities, ensuring timely resolution of technical issues across Phase I–III clinical and commercial products • Oversee formulation development of current approved drugs and new drug candidates • Manage and provide technical oversight of formulation development and cGMP manufacturing activities at contract manufacturing organizations (CMOs) • Support creation of integrated CMC development plans, timelines, budgets, risk assessments, and mitigation strategies to support clinical and commercial milestones • Managing CMOs to develop and maintain methods for clinical/commercial production of finished dosage forms • Review and approve technical and GMP documentation, including specifications, Master Batch records, validation documents, change controls, and technical reports • Author, edit, review, and contribute to CMC sections of regulatory submissions, responses, and health authority interactions • Partner closely with Regulatory Affairs, Quality, Supply Chain, Clinical Operations, and Program Management to ensure alignment of CMC activities with development and commercialization goals • Support regulatory inspections, partner audits, and ongoing compliance with applicable cGMP and global regulatory requirements • Provide technical leadership, mentorship, and strategic guidance across Technical Operations and cross-functional teams • Support launch readiness and commercialization planning to ensure reliable product supply

Job Requirements

  • Bachelor’s degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required
  • 8+ years of relevant experience in cGMP related CMC drug development and manufacturing with emphasis on late-phase clinical development, scale-up, and commercialization
  • Expert knowledge and extensive CMC experience advancing small molecule APIs from process development through process characterization, PPQ, commercialization, and tech transfers in support of solid oral dosage form programs
  • Demonstrated leadership experience in CMC: preferably in more than one related CMC area, and drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity
  • Extensive experience managing global CMOs, third-party manufacturers, and testing labs
  • Broad knowledge and experience with phase-appropriate cGMP requirements and applicable US, EU, and ICH guidelines
  • Demonstrated ability to prepare and review CMC sections of regulatory filings, including INDs, IMPDs, and NDAs
  • Manufacturing experience with oral solid dosage forms
  • Expert knowledge in process validation and technology transfer procedures

Benefits

  • premium health
  • financial, work-life and well-being offerings for eligible employees and dependents
  • wellness and employee support programs
  • life insurance
  • disability
  • retirement plans with employer match
  • generous paid time off

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