Director, Regional Device & Drug Delivery Center of Excellence (RTC)
Core
Lead the design, assembly, validation, and regulatory strategy for drug delivery devices (autoinjectors, pens) for biopharma clients, ensuring safe work practices and quality from concept to commercial scale.
Role type
Senior IC Director of Device Engineering & Center of Excellence
Builds
Combination product devices (autoinjectors, pen injectors) and associated packaging/labeling for pharmaceutical partners
Domain
Medical Devices / Drug Delivery Systems / Biopharma
Required skills
Device design (autoinjector/pen), ISO 14971 risk management, 510(k) regulatory strategy, Root cause analysis (CT/X-ray), Automation strategy, DFM, Team leadership, Client-facing technical communication
Preferred skills
Platform partnerships, Statistical process control, Multi-program portfolio management
Technologies
CT scan, X-ray imaging, High-speed cameras, Metrology equipment, ISO 11608, ISO 11040, ISTA/ASTM standards
Responsibilities
Lead translation of customer User Needs into device strategy; Own Label & Packaging design and DFM; Direct device assembly and test process design; Define automation strategy; Establish in-process controls and metrology; Drive validation philosophy; Provide technical leadership for regulatory submissions; Lead cross-functional RCA investigations; Represent the center in client-facing discussions and proposal development.
Seniority
Director, strategic leadership with hands-on technical oversight