Architect pharmaceutical delivery devices at Ab Cellera, applying design controls and supplier leadership to pre-filled syringes and autoinjectors. Shape combination products for patients.
This Senior/Staff Engineer role drives device development across combination product programs. You will connect hardware engineering with biology while coordinating Quality, Regulatory, Formulation, and Drug Product teams. The work supports antibody therapies advancing toward clinical reality.
Key Responsibilities: Steer delivery device strategy across combination product programs
Build Design History Files, specifications, controls, and trace matrices
Develop Human Factors studies, labeling, and engineering reports
Assess scale-up gaps across fill and assembly sites
Lead suppliers, CDMOs, and technical consultants
Requirements: Eight-plus years device engineering experience for Senior level
Drug delivery and combination product development experience
FDA Design Controls and relevant standards knowledge
External device partner or CDMO management experience
Human Factors and transport simulation study experience
Bring pharmaceutical delivery, design controls, and supplier leadership to Ab Cellera’s pre-filled syringe and autoinjector programs.