Note: The job is a remote job and is open to candidates in USA. Travere Therapeutics is a biopharmaceutical company dedicated to developing life-changing therapies for people living with rare diseases. They are seeking an Associate Director, Technical Operations – Drug Product, who will be responsible for overseeing drug product manufacturing, scale-up, validation, and commercialization processes while collaborating with various internal and external teams.
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
Skills
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or other related discipline required
- 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
- Advanced degree, M.S., or Ph.D. degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Biochemistry, or other related disciplines is preferred
- 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
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
- Combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock)
Company Overview
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