The candidate will support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices.

Primary responsibilities will include:

1) Device/Combination Product Assembly Technical Leadership: Give to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. Provide technical rigor in experimental design and data analysis across projects. Carry out ongoing academic, regulatory and vendor literature review, maintain groundbreaking technical knowledge, and communicate findings to team

2) Assembly Process Characterization: Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination ...