Director – Device Assembly Technology

Job Title: Director – Device Assembly Technology

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 standardization of automated assembly platforms and technical requirements of existing products with focus on efficiency and cost effectiveness. Will work closely with Development teams and manufacturing sites across the network to implement manufacturing 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 projects 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 manufacturing technology development and innovation. Always exploring for next-gen Manufacturing Technologies to ensure that appropriate state-of-the-art manufacturing technology is investigated and implemented when appropriate. Acts as a mentor to engineers within the department to develop and build capabilities.

Scope:

Within Sanofi`s Global Device and Packaging Unit, Process Development & Manufacturing Technology function, the Director – Device Assembly Technology (North America) provides strategic leadership of manufacturing processes, equipment technology, and process development for new and existing Drug-Device Combination products. This position is accountable for defining, and establishing:

• The manufacturing strategy for automated assembly of drug delivery systems throughout design, process development, and industrialization

• Lead a team of manufacturing engineers, and provide technical guidance to the project teams with focus on platform development for manufacturing, and standardization

• Main manufacturing interface with key stakeholders, manufacturing sites, and suppliers

• Drive complex technical support of global investigations

• 25-30% travel

About You

Basic Qualifications:

• Bachelor’s degree required. Preferred degree focus in mechanical engineering, or relevant engineering discipline but will consider all degrees. Advanced degree a plus.

• Minimum 10 years' experience in Medical Device, Pharmaceutical, or Biotechnology industry.

• Deep product design for manufacturing, process development, and manufacturing experience required.

• Thorough knowledge various automated assembly technologies at low and high volume, equipment design and construction, process control strategies, and vision control systems.

• Knowledge of device regulations, quality systems, design fundamentals of combination products, design controls, design transfer, and manufacturing process validation.

• Manufacturing Program Lead of larger projects, proven track record developing manufacturing strategy, providing technical leadership and managing cross-functional teams in execution.

Preferred Qualifications:

• Advanced degree is a plus but is not required.

• Basic knowledge of French or German is a plus.

Soft skills:

• Self-motivated and results oriented

• Ability to influence and negotiate to desired outcome

• Drives decision-making processes with stakeholders inside and outside own perimeter

• Actively takes decisions within scope of responsibility, and is accountable for results

• Presentation and communication skills to influence decision making at senior levels

• Builds relationships and strong partnerships with stakeholders across the organization

• Has a global mindset and the ability to think strategically

Technical skills:

• Proven expertise in pharmaceutical manufacturing, GxP documentation and related Equipment Qualification and Process Validation of high throughput equipment.

• Strong technical skills and familiarity with competitive landscape, industry trends, and regulatory environment.

• Strong analytical, problem solving, and technical writing skills,

• Working competency of statistical programs (e.g. Minitab, SAS)

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
  

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.