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 therapies for people living with rare diseases. The Senior Director, Technical Operations will lead technical strategy and oversight for small molecule API development and manufacturing at contract development and manufacturing organizations, supporting product development, clinical manufacturing, commercialization, and lifecycle management. The role will collaborate with Quality, Regulatory Affairs, Clinical, and Supply Chain teams while advising senior leadership on technical and business-critical decisions.
Responsibilities
- Provide technical oversight of API production, scale up, process characterization, and process performance qualification (PPQ) for a small molecule, solid oral drug product manufactured at Travere CDMOs
- Serve as the senior technical decision authority for assigned programs, evaluating complex technical, regulatory, supply, quality, and financial tradeoffs and recommending actions to senior and executive leadership
- Establish, review and approve manufacturing-related documentation, including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports
- Verify suitability, qualification, and validation status of processes at CDMOs and other external laboratories
- Establish technical direction and provide senior-level leadership and oversight of GMP quality management systems, including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections
- Lead and influence internal and external project teams to support CMC development, clinical supply, commercialization, and lifecycle management of small molecule drug products
- Author and review technical documents and regulatory submission content, including INDs, IMPDs, and NDAs
- Maintain up-to-date knowledge of US and EU GMP requirements, ICH guidelines, and other regulatory expectations applicable to pharmaceutical development and manufacturing
- Review project scope, timelines, and deliverables to ensure CDMO activities meet contractual obligations, quality standards, and program objectives
- Additional duties assigned as needed
Skills
- Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a related discipline required
- Equivalent combination of education and applicable job experience may be considered
- 12+ years of relevant experience (depending on degree) in small molecule API 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
- Extensive experience managing global CDMOs, 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
- Driven, intelligent, passionate about making a difference for patients with rare diseases
- Strong professional experience in a similar role within the pharmaceutical industry, preferably in small molecule development and manufacturing for solid oral dosage forms
- Successful record of creating and managing complex project plans, timelines, budgets, and development and execution of risk mitigation strategies
- 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
- Ability to travel 10-20% domestically and internationally
- All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego
- No role is expected to be 100% remote
- M.S., Ph.D., or other advanced degree in a related discipline preferred
- The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork
- Six Sigma and statistical knowledge is a plus
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