Job Location : Cambridge,MA, USA
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?
Within Sanofi`s Global Device and Packaging Unit, Process Development & Manufacturing Technology function, the Lead Packaging Technology provides strategic leadership of Packaging processes, equipment technology, and materials for new and existing Drug-Device Combination and Vial products. This position is accountable for defining, elaborating and establishing:
Collaborate with cross functional core team, global functions, device & packaging manufacturing sites, and all external supplies (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 ensure 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 with the concepting, prototyping, scaling up and launch of new packaging 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 secondary packaging 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 standardization of packaging platforms and technical requirements of existing products with focus on sustainability and cost effectiveness. Will work closely with Development teams and manufacturing sites across the network to implement the Packaging improvements.
Support evaluation of changes (component, product, process) post design transfer for impact on manufacturing process, and process documentation. Work with manufacturing site and Quality to assess impact and perform equipment trials and re-validation as needed to mitigate risks. Support root cause analysis activities for major manufacturing investigations, provide support to sites, suppliers, and project teams. Leading activities for equipment and process troubleshooting using sound engineering principles, knowledge, experience, and creative problem solving. Implement product or process improvements utilizing design of experiments, and Lean Six Sigma methodologies. Participates in industry forums to identify best in class manufacturing practices and process technologies. Maintain a network of experts to keep the organization at the forefront of packaging development and innovation. Always exploring for next-gen Manufacturing Technologies to ensure that appropriate state-of-the-art packaging technology is investigated and implemented when appropriate.
About You
Basic Qualifications:
Preferred Qualifications:
Technical skills:
Soft skills:
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