Sanofi Group Associate Scientist - Vaccines 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.
Manufacturing Technology (MTech) drives the vaccines industrialization and the improvement of processes and products. It embarks on 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.
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 quality vaccines. It is a multi-disciplinary function that provides expertise in the 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 Manager Associate Scientist Pharma Tech, within the Manufacturing Technology (MTech) function of Vaccine Industrial Affairs performs will support the delivery and maintenance of robust and efficient processes and technology for Formulation, Filling, Lyophilization and Inspection processes. 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.
The individual in this position will (lead or be involved) in cross-functional teams from various functions in IA to deliver the following:
Author technical documents supporting process development and validation. They will participate in technical study execution, Design of Experiment studies (DOE), the generation, analysis, and presentation of data, and support investigations associated with process deviations.
Lead or support technical process improvements and portfolio execution to support the strategy and deliverables across the site
Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines
Secure reliable and sustainable supply
Foster innovative high-performance products and solutions to patients
Authoring and reviewing Pharmaceutical Technology procedures, development, and validation reports
THE JOB RESPONSIBILITIES INCLUDE:
Work with individuals from different disciplines (Quality, Operations, Regulatory, and Engineering)
Write protocols, reports, procedures, and memos as needed to support formulation, filling, and inspection activities as they relate to development and validation
Author protocols and reports, Support validation project timelines
Participate in the preparation and execution of technical studies supporting Formulation and Filling processes
Support investigations related to product and manufacturing processes
Complete DOE (Design of Experiment) studies
Generate, analyze and present data utilizing JMP software
Behaves according to company values and competencies
Influences internally; forward-thinking with an attitude of collaboration, optimization, efficiency, continuous improvement
Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions, and actions for resolution
Proactively resolves conflicts, removes roadblocks to execution within the sphere of influence; escalates to functional management when appropriate
Fosters relationships with partners, experts from other functions, and customers in order to achieve technical objectives
WHO YOU ARE
Sanofi Pasteur’s IA mission is to improve worldwide human health, as a reliable manufacturer, by delivering high-quality, innovative, and affordable products to our customers. You 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).
EDUCATION AND EXPERIENCE
Bachelor of Science Degree in a Scientific or Engineering discipline
5+ years of experience in the validation of Formulation and Filling processes.
Strong technical writing skills
Demonstrated technical aptitude
Working knowledge of JMP software
Strong knowledge of deviation investigation skills
Experience with Design of Experiment (DOE) studies
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.