Director – Device Assembly Technology

Job Title: Director – Device Assembly Technology

Location: Cambridge, MA Morristown, NJ Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The strategic vision of Sanofi’s Global Medical Device and Packaging organization is to lead the industry in device-mediated therapies, with the ambition to develop, launch and maintain best-in-class drug delivery systems and connected medical devices that address patient unmet needs and improve health outcomes. Our specific mission is to support R&D and the Sanofi Commercial Business Units by delivering differentiated technology solutions that enhance the value of our drugs and vaccines and help patients (and health care providers) facilitate administration, thereby improving their quality of life and empowering them to take control of their disease. Our products and solutions sit on top of our market leading technology platforms, are user-centric, innovative, environmentally sustainable, and are continuously improved throughout the life-cycle to meet evolving needs.

We continue to recruit top talent in the industry to help transform the standard of care in the areas of drug delivery devices and stand-alone medical devices. Our teams have developed and released to market auto-injectors, pens, safety syringes, as well as connected medical device technologies, and we are gearing up for more expansive health applications and patient experiences to support the R&D portfolio, including the development of intra-venous devices for home use, on-body drug delivery devices, and targeted delivery systems for cell- and gene therapy, etc. Our commitment to research, development, and manufacturing to deliver cutting-edge technologies has positioned us at the forefront of the drug delivery segment of the pharmaceutical industry.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Collaborate with cross functional core team, global functions, internal device & packaging manufacturing sites, and all external suppliers (equipment, material, and CMO’s) to develop the appropriate manufacturing concept and technology solutions and deploy robust manufacturing solutions.  May act as Manufacturing Lead on large scale global projects.

• Participates in design reviews, provides critical design for manufacturing input to unsure product designs are robust for manufacturing including specification development when needed. Supports sites with process risk assessments, develop and maintain pFMEAs, identify critical process parameters and develop control plans to mitigate risks. Ensure that all product functional requirements are translated into manufacturing requirements and process controls.

• Responsible for supporting new product introductions by providing manufacturing concepts, prototyping, scaling up and launch of new automation assembly solutions. Perform process assessment to determine appropriate manufacturing processes. Proactively work with suppliers to develop, demonstrate manufacturing feasibility, and implement technology solutions. Leads technology development and knowledge transfer activities into internal and external manufacturing sites. 

• Develops the manufacturing strategy, supplier/equipment/technology selection, equipment scale, capital expenditure (CapEx) and project planning (costs, timelines, resources) to meet all manufacturing requirements for the product.  Will partner with procurement and global functions through equipment and supplier request for quotation (RFQ) and selection process.  Will drive the technical capability assessments, and Equipment User Requirement Specifications (URS) for automated assembly processes.

• Manage projects through execution: design review, build, factory acceptance testing, process development, and qualification activities.  Support manufacturing implementation (industrialization) through technology transfer, support sites with knowledge transfer, training, validation plan and execution of IQ/OQ/PQ in accordance with regulatory, company & site requirements. Will often support sites with continuous improvement activities to optimize efficiency, productivity, and asset utilization.

• Lead the improvement and standardizati