Director, Technical Operations (Combination Product Development)
Travere Therapeutics
4 hours ago
Remote
United States
Operations
Position Summary:
Director of Technical Operations (Combination Product Development) – lead device development for a combination product from Phase 3 through regulatory approval, global commercialization, and lifecycle management. Serve as technical lead for device development/combination product activities and ensure alignment with design controls, regulatory requirements, quality standards, and launch objectives in a highly matrixed environment.
Responsibilities:
- Lead the device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
- Drive execution of key milestones: design verification and qualification, process validation (PPQ), BLA submission, and launch readiness
- Act as primary technical liaison between internal stakeholders and external partners/manufacturers
- Manage packaging timelines and deliverables to align with regulatory submission and commercial launch; ensure supply chain and external partner readiness
- Assess external partners (CPOs/CMOs) for technical capability, regulatory compliance, readiness, scalability, and cost effectiveness
- Oversee onboarding/readiness assessments and operational alignment of selected CPOs/CMOs
- Ensure alignment between clinical and commercial packaging; lead transition to commercial manufacturing, including design transfer/process validation, supply chain readiness/launch planning, and final product configuration/control
- Partner with Quality on complaint handling/investigations and post-market surveillance/medical device reporting (e.g., root cause analysis, malfunction/safety)
- Author/review global regulatory submissions for combination products and support regulatory inspection readiness (e.g., Pre-Approval Inspections)
- Participate in Pre-Approval Inspections and routine audits as device SME
- Provide technical input to contract negotiations
- Drive integrated risk management across drug–device interfaces; maintain Post-Market Risk Management file (ISO 14971) using real-world complaint data/trends
- Support continuous improvement and lifecycle management post-approval
Education/Experience Requirements:
- M.S. or Ph.D. in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field (equivalent combination of education/experience considered)
- Minimum 8 years’ experience in device development and commercialization of a combination product
- Strong knowledge of combination product regulatory framework, CMC, and device development (design controls, risk management, verification/validation, design transfer)
Additional Skills/Experience (Required/Preferred):
- Required: Experience with BLA submissions including device constituent components
- Strong pharmaceutical industry experience (preferably biologics development and injectables)
- Expertise managing CPOs/CMOs/external suppliers
- Experience with packaging validation and distribution testing; human factors/usability engineering
- Plus: Background in device or systems engineering
- Preferred: PMP certification; Six Sigma/statistical knowledge
- Prior experience interacting with FDA/other regulatory agencies
- Broad GMP and regulatory affairs knowledge
- Proven ability to manage complex project plans/timelines/budgets and develop risk mitigation strategies
- Ability to adapt to changes in project plans
- Excellent communication, interpersonal/organizational skills, decision-making, and collaboration with strong attention to detail
- Ability to travel 20%–25% domestically/internationally
Benefits (explicitly stated):
- Premium health, financial, work-life and well-being; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
- Target Base Pay Range: $189,000.00–$246,000.00
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
Director of Technical Operations (Combination Product Development) – lead device development for a combination product from Phase 3 through regulatory approval, global commercialization, and lifecycle management. Serve as technical lead for device development/combination product activities and ensure alignment with design controls, regulatory requirements, quality standards, and launch objectives in a highly matrixed environment.
Responsibilities:
- Lead the device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
- Drive execution of key milestones: design verification and qualification, process validation (PPQ), BLA submission, and launch readiness
- Act as primary technical liaison between internal stakeholders and external partners/manufacturers
- Manage packaging timelines and deliverables to align with regulatory submission and commercial launch; ensure supply chain and external partner readiness
- Assess external partners (CPOs/CMOs) for technical capability, regulatory compliance, readiness, scalability, and cost effectiveness
- Oversee onboarding/readiness assessments and operational alignment of selected CPOs/CMOs
- Ensure alignment between clinical and commercial packaging; lead transition to commercial manufacturing, including design transfer/process validation, supply chain readiness/launch planning, and final product configuration/control
- Partner with Quality on complaint handling/investigations and post-market surveillance/medical device reporting (e.g., root cause analysis, malfunction/safety)
- Author/review global regulatory submissions for combination products and support regulatory inspection readiness (e.g., Pre-Approval Inspections)
- Participate in Pre-Approval Inspections and routine audits as device SME
- Provide technical input to contract negotiations
- Drive integrated risk management across drug–device interfaces; maintain Post-Market Risk Management file (ISO 14971) using real-world complaint data/trends
- Support continuous improvement and lifecycle management post-approval
Education/Experience Requirements:
- M.S. or Ph.D. in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field (equivalent combination of education/experience considered)
- Minimum 8 years’ experience in device development and commercialization of a combination product
- Strong knowledge of combination product regulatory framework, CMC, and device development (design controls, risk management, verification/validation, design transfer)
Additional Skills/Experience (Required/Preferred):
- Required: Experience with BLA submissions including device constituent components
- Strong pharmaceutical industry experience (preferably biologics development and injectables)
- Expertise managing CPOs/CMOs/external suppliers
- Experience with packaging validation and distribution testing; human factors/usability engineering
- Plus: Background in device or systems engineering
- Preferred: PMP certification; Six Sigma/statistical knowledge
- Prior experience interacting with FDA/other regulatory agencies
- Broad GMP and regulatory affairs knowledge
- Proven ability to manage complex project plans/timelines/budgets and develop risk mitigation strategies
- Ability to adapt to changes in project plans
- Excellent communication, interpersonal/organizational skills, decision-making, and collaboration with strong attention to detail
- Ability to travel 20%–25% domestically/internationally
Benefits (explicitly stated):
- Premium health, financial, work-life and well-being; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
- Target Base Pay Range: $189,000.00–$246,000.00
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.