Manager Senior Process Engineer- Vaccines

Job Title: Manager Senior Process Engineer- Vaccines

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.

Manufacturing and Supply (M&S) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi provides associates in M&S a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.

This position of Industrial Affairs Senior Process Engineer / Scientist, within the Manufacturing Sciences, Analytics, and Technology (MSAT) function of Industrial Affairs, performs activities supporting the development, validation and continuous improvement of Drug Product and Buffer Formulation.  The mission of the MSAT function is to deliver robust and efficient processes & testing with associated knowledge to transfer to Manufacturing. The MSAT function also provides daily support to manufacturing toward industrial performance excellence.  The individual in this position will:

• Drive the technical strategy and project deliverables across the Formulation Excellence (Drug Product) landscape for multiple projects across the Swiftwater site.

• Serve as a Product & Process Specialist (SPP) for general pharmaceutical technologies, transfers and change management implementation with emphasis on Drug Product and Buffer Formulation Processes.

• Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines.

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:

• Function as the platform’s Drug Product and Buffer Formulation SPP.
• Lead and deliver technical studies and validation strategies for Manufacturing assist, Technology Transfers and New Vaccines formulation operations.
  • Provide Shop Floor assistance to support investigations, troubleshooting, CAPA and Change Control activities.
  • Author / review / approve process design specifications and validation project plans.
  • Author / review / approve technical documents which support project execution and manufacturing assistance.
  • Participate, support, defend and provide technical expertise during Pre-Approval Inspections and agency inspections when required to defend studies.

• Having a strong working knowledge of the relationship between Drug Product and buffer formulation characteristics and critical quality attributes.
• Working with different disciplines (Quality, Manufacturing Operations, Regulatory Affairs, and Engineering) in the execution of development and validation studies to industrialize processes for clinical and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and biopharmaceuticals.
• Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.
• Providing technical coaching, training and guidance to junior process engineers/scientists on drug product and buffer formulation related subject matter.
• Leading tactical responses to process deviations, delivering technical solutions and communicating outcomes to site management.
• Promote innovation to keep up to date with the latest regulatory expectations and industry trends.

About You

Education and experience

• Bachelors in Basic Sciences, Pharmacy, Chemical Engineering or Mechanical Engineering required.

• 10 years of experience with drug substance, buffers, and / or drug product development and validation processes.

• Knowledge of the design, operation and peripheral processes associated with formulation activities.

Preferred Skills:

• Masters in Basic Sciences, Pharmacy, Chemical Engineering or Mechanical Engineering.

• Strong technical writing skills.

• Attitude of collaboration.

• Ability to coach junior staff members.

• eDoc, SAP, Track wise proficiency.

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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