Position Summary:
The Associate Director, Technical Operations – Drug Product, is responsible for drug product manufacturing, scale up, validation, and commercialization of a small molecule, solid oral drug product. The successful candidate enjoys managing external CDMOs and collaborating closely with colleagues in Technical Operations, Quality, Regulatory CMC, Clinical, and Supply Chain. This position is a key CMC contributor for the clinical development through the commercialization of a small molecule drug product for a rare disease indication.
Responsibilities:
- Technical oversight of production, scale up, process characterization, and process performance qualification (PPQ) of drug product manufacture of a small molecule, solid oral product at Travere’s CDMOs.
- Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, process characterization, and validation protocols/reports.
- Verify suitability, qualification, and validation of processes at CDMOs and other external laboratories.
- Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
- Collaborate on CMC development and commercialization of drug product with internal and external project teams.
- Author and review technical documents and regulatory filings, including INDs, IMPDs, and NDAs.
- Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production.
- Review project scope and ensure that contractual obligations of CDMOs meet quality standards and timelines.
- Provide technical recommendations to leadership regarding CDMO performance, process readiness, validation strategy, regulatory risks, and commercialization milestones.
- Additional duties assigned as needed.
Education/Experience Requirements:
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline required. Equivalent combination of education and applicable job experience may be considered. Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred.
- 8+ years of relevant work experience including small molecule drug product manufacturing with a focus on scale-up, late phase clinical development, and commercialization.
- Manufacturing experience with amorphous solid dispersions (spray dried amorphous dispersions preferred); solid oral drug product (granulation, capsules and tablets) development experience a plus.
- Expert knowledge in process development, characterization studies, PPQ, and commercialization for solid oral products, with emphasis on amorphous solid dispersions.
- Skilled in preparation of CMC modules of regulatory filings such as INDs, IMPDs, and NDAs.
- Extensive experience managing global CDMOs and/or third-party manufacturers and testing labs.
- Broad knowledge and experience with phase-appropriate cGMP requirements and US, EU, and ICH guidelines.
Additional Skills/Experience:
- The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork
- 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 solid oral development and manufacturing.
- Successful record of creating and managing complex project plans, timelines, and budgets, and development 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.
- Six Sigma and statistical knowledge is a plus.
- 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.
Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.
Benefits:
Our benefits include 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 and generous paid time off.
Compensation:
Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Target Base Pay Range:
$150,000.00 - $195,000.00
*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location.
