Senior Executive, Drug Device Combination Product | Product Delivery Development
Core
Develop and optimize pharmaceutical packaging systems for drug-device combination products, ensuring product protection, stability, compliance, and patient usability.
Role type
Senior IC packaging development engineer (drug-device combination products)
Builds
Primary and secondary packaging components for pharmaceutical products
Domain
Pharmaceutical industry + regulatory compliance
Required skills
Drug-device combination product development, regulatory requirements, QMSRs, ISO/ASTM standards, design controls for devices, compatibility and stability studies, technology transfer, risk management (ISO 14971), human factors studies, supplier management
Preferred skills
M. Pharm degree, 5-8 years experience
Technologies
QMSR, ISO 14971, DHFs
Responsibilities
Review change controls for drug-device combination products, prepare and review study protocols and reports, coordinate with Quality Management to compile Design History Files, draft Threshold/Comparative Analysis and Human Factors Study protocols, prepare risk management documents, interact with device development suppliers and testing institutions
Seniority
Senior, hands-on IC