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Sanofi Group Dep Director Principal Engineer - Vaccine in Swiftwater, Pennsylvania

WHO WE ARE

Sanofi Pasteur is the vaccines division of Sanofi. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is located in northeast Pennsylvania and is home to the production of over 140 million doses of vaccine each year.

The Manufacturing Technology (MTech) drives the vaccines industrialization and the improvement of processes and products. It embarks new technologies and digital trends and is the keeper of manufacturing process knowledge. MTech is at the crossroads of R&D and production as the team is spread over 9 production sites.

A close collaboration with R&D to ensure that the processes for new vaccines are as innovative and standardized as possible to guarantee efficacy, cost-effectiveness, and rapid time to market of quality vaccines. It is a multi-disciplinary function that provides expertise in process; manufacturing sciences, process modeling, statistical analysis; process validation and technology transfer. Commitment and solidarity are key in the MTech department. The Global MTech organization is the seeding ground for technical and scientific talents that execute their work in a large network and offer multiple possible career evolutions. You will be integrated into a team where you will acquire scientific and technical skills, alongside our experts, our data scientists, our project teams, a management team committed to your development. Furthermore, Global MTech is providing cross-functional training and development and is the portal for collaboration with many different organizations including R&D, Manufacturing, Supply Chain, Regulation and Quality.

THE POSITION

The Site Materials Science Subject Matter Expert, within the Manufacturing Technology (MTech) function of Vaccine Industrial Affairs performs a key function within the Manufacturing Technology (MTech) Process Technology Platform of Vaccine Industrial Affairs. The role is responsible for managing, optimizing, and executing the Swiftwater Site Materials Science Program and partners with all functions across the site to continuously improve the level of knowledge and skills around single use systems and their application, define the strategic vision for the Site Material Science program, support commercial manufacturing investigations, and represent the Site during Health Authority inspections related to material science. The mission of the MTech function is to deliver robust and efficient processes with associated knowledge to transfer to Manufacturing. The MTech function also provides daily support to manufacturing toward industrial performance excellence.

RESPONSIBILITIES

  • Evaluate, develop, and improve the Site Materials Science Program, including providing guidance during investigations, corrective and preventative actions, and manufacturing investigations

  • Ensure compliance with all regulatory requirements and quality standards are followed to provide a safe, efficacious, quality product.

  • Represent the Site during Health Authority inspections related to material science and lead the implementation of any commitments that result from those inspections.

  • Leads and/or supports Site development and manufacturing activities related to material science, such as:

  • designing and developing single use systems

  • providing expert guidance for single use system design, quality management, and testing

  • assessing proposals for single use system changes to determine impact and define deliverables

  • Network with other subject matter experts within the Sanofi network and across the industry to understand trends, develop best practices, and make recommendations for improvements to be implemented in Swiftwater.

  • Creates and maintains the Materials Science Program document to define the near-, mid-, and long-term vision for development of Site practices and procedures.

BASIC QUALIFICATIONS:

  • Bachelor’s degree required in one of the following disciplines: in basic sciences, math, engineering, or pharmacy with 6+ years’ industry experience OR

  • M.S. with 1+ years’ experience in biological processes in a cGMP environment.

  • The candidate should possess educational and professional experience, commensurate with the position.

PREFERRED QUALIFICATIONS:

  • M.S. with 3 to 5 years’ experience supporting single use system design and quality management for commercial production of biological sterile injectables.

  • Strong knowledge of regulatory expectations around design, quality management, and testing of single use systems.

TERMS OF EMPLOYMENT

  • The hired candidate will execute role as an individual contributor.

  • Preferred start date: November 2021

  • The hired candidate will work during normal business hours (8am – 5pm Monday – Friday), but flexibility for occasional work outside of these hours is necessary.

BENEFITS OF WORKING IN THIS ROLE

Sanofi Pasteur’s VIA mission is to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers. Therefore, the hired candidate will:

  • fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).

  • have the opportunity to establish the vision and set the strategic direction of the Site Material Science Program

  • have the opportunity to influence best practices related to single use systems throughout various manufacturing facilities (drug substance and drug products), both within Sanofi Pasteur as well as across the global Sanofi network.

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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