Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company focused on developing and delivering life-changing therapies for people living with rare diseases. The Associate Director, Technical Operations leads the CMC strategy for a portfolio of small molecules, overseeing development, manufacturing, external partners, regulatory activities, and cross-functional risk mitigation.
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
- Bachelor's degree in Process or Chemical Engineering, Life Sciences, or related discipline required. Equivalent combination of education and applicable job experience may be considered
- 8 years of progressive cGMP related CMC drug development or manufacturing experience required
- Must show demonstrated leadership experience in CMC:
- Drug development experience with small molecules (both oral and injectable), peptides, and biologics of varying degrees of complexity
- Advanced knowledge of process validation, technology transfer, manufacturing controls, and phase-appropriate cGMP requirements
- Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
- Team player and strong interpersonal and organizational skills and excellent verbal and written communication skills
- Excellent decision-making and collaboration skills with strong attention to detail
- Preferably in more than one related CMC area
- Manufacturing experience with oral solid dosage forms
Benefits
- Premium health offerings for eligible employees and dependents
- Financial offerings for eligible employees and dependents
- Work-life offerings for eligible employees and dependents
- Well-being offerings for eligible employees and dependents
- Wellness and employee support programs
- Life insurance
- Disability benefits
- Retirement plans with employer match
- Generous paid time off
- Short-term incentive compensation
- Long-term incentive compensation in the form of company stock
Company Overview
Company H1B Sponsorship