Medical Device Platform Lead - Ocular Port Delivery Device platform

Roche•South San Francisco, CA

About The Position

Pharma Technical Operations (PT) is responsible for manufacturing, supply chain, and quality across the pharmaceutical network. Within PT, PTT (MSAT & Engineering) is responsible for ensuring that PT stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network. Global Device, Packaging and Distribution MSAT ensures our device-related products including platforms and packaging systems are robustly engineered, efficiently manufactured, and safely delivered and maintained. The Ocular Port Delivery Platform Lead sets the strategy for the device platform within Roche’s device portfolio responsible for developing, adapting, and maintaining a global device and packaging lifecycle strategy (from development, implementation, supply) for the Ocular Port Delivery Device platform and associated development projects with a 5-10 year planning horizon. The Opportunity You are responsible for guiding the design and standardization of the Ocular Port Delivery Device platform core technology across all of Roche's drug products, creating a single, integrated pathway from development to commercial manufacturing. Own the end-to-end device platform strategy supporting molecule projects ranging from preclinical (pre-phase 1) development through post-commercial product updates. Provide a mature device platform device portfolio to product teams at appropriate robustness (cost, supply, quality). Oversee and guide technical teams that are responsible for tactically creating, deploying and maintaining the platform technology solutions across the product life cycle supporting development and commercial teams. Oversight of implementing molecule-agnostic device platform families into development projects, embedding industrialization and commercialization requirements early, and translating the end-to-end platform strategy into consistent, scalable, and efficient utility. Manage a technical team capable of driving platform development and maturation including molecule agnostic activities related to design technology and respective DHF library in support of product registration, launch, and post-market sustaining engineering activities. Ensure that the technology team provides sound technical rigor utilizing product design/process engineering expertise rooted in design excellence as well as effectively deploying the platform basis into product teams by creating and maintaining device platform DHFs ensuring the benefits of speed, quality, and standardization across the entire life cycle. Support/Guide technical teams related to platform design (product and process) ensuring platform based combination products can be industrialized at the appropriate scale. Who you are You bring solid matrix leadership skills to lead a team developing/industrializing a device/combination product through all stages of Design Review, providing clear prioritization of platform goals and enabling collaborative decision making in the teams.

Requirements

solid matrix leadership skills to lead a team developing/industrializing a device/combination product through all stages of Design Review, providing clear prioritization of platform goals and enabling collaborative decision making in the teams
B.S./M.S/Ph.D. degree in science, engineering, or a related field
10+ years’ total work experience with at least 8 or more years’ relevant experience in medical device or combination product development
Proven track record of technical accomplishments in medical device/drug-device integrated combination product & packaging development and commercialization with an advanced knowledge of the Pharma/Medtech industry with excellent know-how of the Design and Development Process of Medical Devices /Combination Products including Design Controls
Knowledge of various Device/Combination Product manufacturing processes and platforms and the relevant GMP quality and regulatory dependencies
Deep understanding of the supplier/external partner landscape in the areas of medical devices, primary as well as secondary packaging

Nice To Haves

Prior experience in preclinical research, clinical device development, and/or ophthalmology devices is preferred

Responsibilities

guiding the design and standardization of the Ocular Port Delivery Device platform core technology across all of Roche's drug products, creating a single, integrated pathway from development to commercial manufacturing
owning the end-to-end device platform strategy supporting molecule projects ranging from preclinical (pre-phase 1) development through post-commercial product updates
providing a mature device platform device portfolio to product teams at appropriate robustness (cost, supply, quality)
overseeing and guiding technical teams that are responsible for tactically creating, deploying and maintaining the platform technology solutions across the product life cycle supporting development and commercial teams
implementing molecule-agnostic device platform families into development projects, embedding industrialization and commercialization requirements early, and translating the end-to-end platform strategy into consistent, scalable, and efficient utility
managing a technical team capable of driving platform development and maturation including molecule agnostic activities related to design technology and respective DHF library in support of product registration, launch, and post-market sustaining engineering activities
ensuring that the technology team provides sound technical rigor utilizing product design/process engineering expertise rooted in design excellence as well as effectively deploying the platform basis into product teams by creating and maintaining device platform DHFs ensuring the benefits of speed, quality, and standardization across the entire life cycle
supporting/Guiding technical teams related to platform design (product and process) ensuring platform based combination products can be industrialized at the appropriate scale

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