Director, Technical Operations (Combination Product Development)

The Director of Technical Operations (Combination Product Development) leads device development of a combination product program from late-stage development through regulatory approval, global commercialization, and lifecycle management.

Requirements

• Lead the device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
• Drive execution against key milestones including design verification and qualification, process validation (PPQ), BLA submission, and launch readiness
• Serve as the primary technical liaison between internal stakeholders and external partners and manufacturers
• Manage packaging timelines and deliverables to align with regulatory submission and commercial launch milestones
• Assess external partners such as Contract Packaging Organizations (CPOs) and Contract Manufacturing Organizations (CMOs)
• Oversee implementation of selected CPOs and CMOs, including onboarding, readiness assessments, and operational alignment
• Ensure alignment between clinical and commercial packaging configurations and lead transition from development to commercial manufacturing
• Partner with Quality to drive complaint handling and investigation as well as post-market surveillance and medical device reporting
• Author and/or review global regulatory submissions for combination product and ensure regulatory inspections readiness
• Participate in Pre-Approval Inspections and routine audits as device SME
• Support contract negotiations by providing technical input on scope, capabilities, and operational feasibility
• Drive integrated risk management across drug–device interfaces
• Support continuous improvement and lifecycle management post-approval

Benefits

• Premium health insurance
• Financial insurance
• Wellness and employee support programs
• Life insurance
• Disability insurance
• Retirement plans with employer match
• Generous paid time off