Director, Technical Operations (Combination Product Development)
Travere Therapeutics
4 hours ago
Remote
United States
Operations
Position Summary:
The Director of Technical Operations (Combination Product Development) leads device development for a combination product program from Phase 3 through regulatory approval, global commercialization, and lifecycle management. Serves as technical lead for device/combination product activities, ensuring alignment with design controls, regulatory requirements, quality standards, and launch objectives in a highly matrixed environment.
Responsibilities:
- Lead device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
- Drive key milestones: design verification/qualification, process validation (PPQ), BLA submission, and launch readiness
- Act as primary technical liaison between internal stakeholders and external partners/manufacturers
- Manage packaging timelines/deliverables for regulatory submission and commercial launch; ensure supply chain and partner readiness
- Assess CPO/CMO partners on technical capability, regulatory compliance, readiness, scalability, and cost effectiveness
- Oversee CPO/CMO onboarding, readiness assessments, and operational alignment
- Align clinical vs. commercial packaging configurations and manage transition to commercial manufacturing (design transfer, process validation, supply chain readiness, final configuration/control)
- Partner with Quality on complaint handling, post-market surveillance, and device reporting (e.g., root cause, malfunction, safety)
- Author/review global combination product regulatory submissions (e.g., BLA with device constituent) and ensure inspection readiness (e.g., Pre-Approval Inspections)
- Participate in Pre-Approval Inspections and routine audits as device SME
- Provide technical input for contract negotiations (scope, capabilities, feasibility)
- Drive integrated risk management across drug–device interfaces; update Post-Market Risk Management (ISO 14971) using real-world complaint data
- 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 (or equivalent education + applicable experience)
- Minimum 8 years of relevant experience in combination product device development and commercialization
- Strong knowledge of combination product regulatory framework, CMC, and device development (design controls, risk management, verification/validation, design transfer)
Required/Preferred Skills & Experience:
- Required: Experience with BLA submissions including device constituent components
- Strong experience in similar pharmaceutical roles (preferably biologics development and injectables)
- Expertise managing CPOs/CMOs/external suppliers
- Experience with packaging validation and distribution testing; human factors/usability engineering
- Preferred: Background in device/system engineering; PMP certification; Six Sigma/statistical knowledge
- Prior experience interacting with FDA/other regulatory agencies
- Broad GMP and regulatory affairs knowledge; ability to build/manage complex project plans, timelines, budgets, and risk mitigation strategies
- Ability to adapt to project changes; strong interpersonal/organizational and verbal/written communication skills
- Ability to travel 20–25% domestically and internationally
Benefits:
- Benefits include premium health and financial/work-life well-being offerings, wellness and employee support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Director of Technical Operations (Combination Product Development) leads device development for a combination product program from Phase 3 through regulatory approval, global commercialization, and lifecycle management. Serves as technical lead for device/combination product activities, ensuring alignment with design controls, regulatory requirements, quality standards, and launch objectives in a highly matrixed environment.
Responsibilities:
- Lead device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
- Drive key milestones: design verification/qualification, process validation (PPQ), BLA submission, and launch readiness
- Act as primary technical liaison between internal stakeholders and external partners/manufacturers
- Manage packaging timelines/deliverables for regulatory submission and commercial launch; ensure supply chain and partner readiness
- Assess CPO/CMO partners on technical capability, regulatory compliance, readiness, scalability, and cost effectiveness
- Oversee CPO/CMO onboarding, readiness assessments, and operational alignment
- Align clinical vs. commercial packaging configurations and manage transition to commercial manufacturing (design transfer, process validation, supply chain readiness, final configuration/control)
- Partner with Quality on complaint handling, post-market surveillance, and device reporting (e.g., root cause, malfunction, safety)
- Author/review global combination product regulatory submissions (e.g., BLA with device constituent) and ensure inspection readiness (e.g., Pre-Approval Inspections)
- Participate in Pre-Approval Inspections and routine audits as device SME
- Provide technical input for contract negotiations (scope, capabilities, feasibility)
- Drive integrated risk management across drug–device interfaces; update Post-Market Risk Management (ISO 14971) using real-world complaint data
- 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 (or equivalent education + applicable experience)
- Minimum 8 years of relevant experience in combination product device development and commercialization
- Strong knowledge of combination product regulatory framework, CMC, and device development (design controls, risk management, verification/validation, design transfer)
Required/Preferred Skills & Experience:
- Required: Experience with BLA submissions including device constituent components
- Strong experience in similar pharmaceutical roles (preferably biologics development and injectables)
- Expertise managing CPOs/CMOs/external suppliers
- Experience with packaging validation and distribution testing; human factors/usability engineering
- Preferred: Background in device/system engineering; PMP certification; Six Sigma/statistical knowledge
- Prior experience interacting with FDA/other regulatory agencies
- Broad GMP and regulatory affairs knowledge; ability to build/manage complex project plans, timelines, budgets, and risk mitigation strategies
- Ability to adapt to project changes; strong interpersonal/organizational and verbal/written communication skills
- Ability to travel 20–25% domestically and internationally
Benefits:
- Benefits include premium health and financial/work-life well-being offerings, wellness and employee support programs, life insurance, disability, retirement plans with employer match, and generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.