Sanofi Group Scientist Manager in Swiftwater, Pennsylvania
Role: Cleaning Development and Validation, Manufacturing Technology
HR Title: Laboratory and Process Development Scientist, L2-1
Vaccines Industrial Affairs, Swiftwater, Pennsylvania, USA
Who We Are
Sanofi Pasteur Vaccines 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 biopharmaceuticals.
The Cleaning Development and Validation scientist, working within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs (VIA), will perform process-related cleaning development and validation activities across the MTech portfolio . The mission of the MTech function is to deliver robust and efficient processes, with associated know how, to the Manufacturing shop floor. The MTech function also provides daily support to manufacturing, with the goals of securing a reliable and sustainable vaccine supply, enabling the VIA network and partnership development for market access expansion, and fostering innovative high-performance products and solutions to patients.
The Portfolio Validation team, part of the Performance Excellence and Portfolio Management (PEPM) platform of MTech Swiftwater, designs and executes qualification and validation studies across the areas of cleaning validation, filter validation, shipping qualification and validation, and extractable/leachable qualification.
The individual in this position will lead or be involved in cross-functional teams from across VIA to deliver the following:
Leading or supporting technical process improvements and portfolio execution
Defining and managing deliverables and objectives for safe and compliant execution
Demonstrating cross-functional teamwork across platforms in MTech, VIA, R&D, and external to Sanofi
Effectively communicating information to site management and site senior management
Supporting the site for all internal and external audits and regulatory inspections
Coaching, training and development of employees
THE JOB RESPONSIBILITIES INCLUDE:
Subject matter expert/technical expert in cleaning validation and point of contact for notebook, development and validation study design and execution
Technical contributions to the strategic vision for the future of cleaning validation and implementation at the Swiftwater site
Participation in the cleaning validation network within Sanofi Pasteur
Maintaining technical knowledge in the workforce
Completion and maintenance of all training required to author documents and to execute qualification and validation studies, including building access
Direct interaction with project teams, quality support functions and production personnel
Who You Are
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. The successful candidate would fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity). Expected competencies include:
Influencing internally and across VIA functions; forward thinking with an attitude of collaboration, optimization, efficiency and continuous improvement
Proactively anticipating and effectively communicating success, constraints, conflicts, solutions and actions for resolution
Proactively resolving conflicts, removing roadblocks to execution within sphere of influence; escalating to functional management when appropriate
Fostering relationships with partners, experts from other functions and customer in order to achieve technical objectives
Education and experience
Bachelor's degree in Engineering, Biological Science, or Chemistry with 5 years industry experience
Master's degree in Engineering, Biological Science, or Chemistry with 2 years industry experience
Master's degree in Pharmaceutical Manufacturing preferred
A minimum of two years experience in the design and execution of cleaning validation studies in a regulated environment, additional experience in other areas of validation (filter, shipping, extractables/leachables) is a plus
Proven experience leading or participating in cross-functional teams
Excellent writing, communication and organizational skills
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.