Director, Combination Products & Device Development
Core
Architect device platform strategy and oversee design controls to advance drug-device combination products (prefilled syringes, autoinjectors) through commercial launch.
Role type
Director, Combination Products & Device Development
Builds
Drug-device combination products including prefilled syringes and autoinjectors
Domain
Biotechnology / Pharmaceutical delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Device engineering, design controls, regulatory compliance (FDA 21 CFR 820.30, ISO 13485), Human Factors Engineering, risk management, CDMO management, supply chain strategy, quality management systems
Preferred skills
Experience with parenteral presentation distribution/transport simulation, antibody therapy development
Technologies
None explicitly listed
Responsibilities
Provide strategic leadership for design, development, verification, validation, transfer, and commercialization of combination products; oversee design control activities and DHF deliverables; develop and mentor engineering teams; oversee Human Factors strategies and regulatory documentation; lead device-related risk management and technical due diligence; drive external technical partnerships with CDMOs and suppliers; serve as strategic owner for the drug-device interface; guide packaging, shipping, and distribution strategies; partner with Quality, Regulatory, and Supply Chain teams to maintain quality management systems; oversee regulatory documentation for global submissions.
Seniority
Director, strategic leadership with hands-on technical oversight
