Senior/Staff Engineer, Pharmaceutical Delivery
Core
Architect design control frameworks and lead strategic supplier partnerships to develop pharmaceutical delivery devices (prefilled syringes, autoinjectors) for antibody therapies.
Role type
Senior/Staff Engineer, Pharmaceutical Delivery
Builds
Drug-device combination products for clinical-stage antibody therapies
Domain
Biotechnology / Pharmaceutical Delivery Systems
Deliverable
physical/clinical work
Required skills
Device engineering (mechanical/biomedical/chemical), Drug delivery systems, FDA Design Controls (21 CFR 820.30, Part 4), Human Factors Engineering, CDMO management, Distribution simulation studies
Preferred skills
Parenteral drug delivery exposure, Safety systems experience
Technologies
ISO 13485, ISO 11608, ISO11040, ISO 14971, IEC 62366
Responsibilities
Lead Design History File creation, Develop Human Factors program and author labeling, Conduct gap analysis for scale-up, Manage external device partners/CDMOs, Own drug-device interface, Lead packaging and shipping evaluation designs, Author device sections for clinical submissions
Seniority
Senior (8+ years exp) / Staff (12+ years exp)
