Director Aseptic Process Subject Matter Expert
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
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Director Aseptic Process Subject Matter Expert
(Swiftwater, PA)The Director Aseptic Process SME is a key member of the Formulation, Filling, Inspection, & Packaging (FFIP) Leadership Team and is responsible for compliance and execution of the aseptic programs in FFIP. This role will partner with all functions across the site to continuously improve the level of knowledge and skills around Aseptic Processing in FFIP and for the Site. The Aseptic Process SME will be a key member of the FFIP Leadership Team and Management Committee that will implement the strategic vision to have Swiftwater (SWR) become the Center of Excellence for Aseptic Filling.
The Director Aseptic Process SME is responsible for the Aseptic Process in both the Formulation and Filling operations for all products that are produced at the SWR site. That includes both vial and syringe formats of ~120 Million Doses. That is accomplished through the partnership across all functions that support FFIP in developing an Aseptic Program that ensures all products produced are safe, quality, and effective. Decisions made by the Aseptic Process SME have the potential to impact the business by interrupting manufacturing and losing millions of dollars of lost production revenue each day.
- Participate as a key member to the Aseptic Process Design Team to evaluate our APS Program and monitor execution of those activities. This includes being the Operations representative during any assessments and investigations for the Aseptic Process. They will work closely with Aseptic Process Monitoring team to assess aseptic risk on site and develop corrective plans to ensure we manage that risk appropriately.
- Ensure compliance with all regulatory requirements and quality standards are followed to provide a safe, quality, and effective product. Represent Operations in Health Authority inspections related to Aseptic Process areas and the implementation of any corrective actions as a result of those inspections.
- Leads and/or supports manufacturing activities as it relates to Aseptic Processing. Such as: Aseptic training program, Operator Qualification, APS Scheduling & Execution, Escalation of Aseptic challenges to the Aseptic Process Design Team to get cross-functional alignment, and Aseptic Technique periodic observation and coaching to improve knowledge at all levels in Operations
- Network with other Aseptic SME’s within the Sanofi network and within the industry to understand trends and best practices, and make recommendations for improvements to be made in SWR.
- Travel is less than 5% and will particiapte in industry forums and conferences.
*Bachelors degree in Science, Engineering or Business
*10 years of Biopharmaceutical Manufacturing experience
* 7 years of Aseptic Technique and Health Authority expectations around Aseptic Processes.
*5 years leading teams and working with cross-functional teams for Continuous Improvement.
*Aseptic Gown Qualified or the ability to gain Aseptic Gown Qualification.
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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