Sanofi Group Deputy Director Cleaning Subject Matter Expert - Vaccine in Swiftwater, Pennsylvania
Deputy Director Cleaning Subject Matter Expert
Location: Swiftwater, PA
Who We Are:
Vaccine Industrial Affairs (VIA), 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 bio-pharmaceuticals. Sanofi Pasteur provides associates in IA 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.
The mission of MTech function is to deliver robust and efficient process & testing with associated know how transfer to Manufacturing & QC. MTech function also provides daily support manufacturing and QC toward industrial performance excellence.
TheSite Cleaning Subject Matter Expert is a key member of the Process Technology Platform within the Manufacturing Technology (MTech) function of Vaccine Industrial Affairs and is responsible for managing, optimizing, and executing the Swiftwater Site Cleaning Program. The role partners with all functions across the site to continuously improve the level of knowledge and skills around cleaning cycle development and validation for product contact equipment, define the strategic vision for cleaning process improvement, support commercial manufacturing investigations, and represent the Site during Health Authority inspections related to cleaning processes.
Evaluate, develop, and improve the Site Cleaning Program, including providing guidance during manufacturing investigations, as well as corrective and preventative actions.
Ensure Site Cleaning Program 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 cleaning processes for product contact equipment and lead the implementation of any commitments that result from those inspections.
Lead and/or support Site development and manufacturing activities related to cleaning processes for product contact equipment, such as:
Developing cleaning cycles.
Providing expert guidance to define cleaning validation study strategies.
Assessing proposals for cleaning process 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.
Create and maintain the Site Cleaning Program strategy to define the near-, mid-, and long-term vision for development of Site practices and procedures.
Mentor, train, and communicate with Site Cleaning Program team members, customers, and stakeholders.
A Master's degree required within one of the following fields of study: basic sciences, math, engineering, or pharmacy with 6+ years’ experience within a cGMP environmentOR
A PhD with 1+ years’ experience in biological processes within a cGMP environment.
The candidate should possess educational and professional experience, commensurate with the position.
A PhD with 3-5 years’ experience supporting cleaning cycle development and validation activities for commercial production of biological sterile injectables.
Strong knowledge of regulatory expectations around cleaning process development and validation.
Terms of employment:
The hired candidate will execute role as an individual contributor with high autonomy.
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 evolve the vision and drive the strategic direction of the Site Cleaning Program.
Have the opportunity to influence cleaning best practices throughout various manufacturing facilities (drug substance and drug products) within Sanofi Pasteur, throughout the global Sanofi network, and across the industry through active participation in external professional forums.
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.
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.