Sanofi Group Manager – 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.
This position of Industrial Affairs Manager Senior Scientist, in the Manufacturing Technology (Mtech) function of Industrial Operations, leads design and execution of technical studies at a small scale to support industrialization of processes for Phase 3 and licensed products to assure commercialization. The mission of MTech is to deliver robust and efficient processes & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
Serve as a subject matter expert for manufacturing processes of Lyophilized and Clinical Liquid products.
Serve as a Subject Matter Expert (SME) for filter technologies for existing Drug Products, technology transfers, and new vaccines
This position will lead small-scale process development activities in the formulation area of specialization with high technical and scientific complexity. Technical studies and scientific expertise will help in establishing robust drug product manufacturing processes.
Drive the technical strategy, team collaboration, and project deliverables across the Pharmaceutical Technology landscape for multiple projects across the Swiftwater site
Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines
Encourages and ensures proactive and strong collaboration internally and across VIA functions; forward-thinking with an attitude of optimization, efficiency, continuous improvement, and smooth transitions between functions
The individual in this position will contribute to cross-functional teams from various functions in IA to deliver the following:
Matrix cross-functional leadership and strong understanding of project management/business/financial and life cycle management of projects with focus and understanding of CMC.
Delivering Manufacturing Assistance and Clinical Project leadership in support of the strategic vision of the product.
Anticipating variations in schedules, skill needs, and conflicts to efficiently utilize resources, including planning for peaks in workload
Author and train appropriate audience to study protocols
Author development reports that summarize small scale study results and support large scale formulation manufacturing processes
Support the scale-up of formulation processes developed in a small-scale lab.
The Job Responsibilities Include
Supporting the formulation and filling manufacturing processes for Lyophilized products
Leading clinical formulation and filling activities within the Line 9 Manufacturing area.
Serving as Liaison between MTech, Manufacturing, Quality Operations, Project teams, etc. and assist to troubleshoot or resolve any issues that arise
Completion of Development, Validation, and Transfer of pharmaceutical technologies for release and stability of clinical and commercial products according to project needs and timelines across the Formulation, Filling, Inspection, and Packaging (FFIP) platform
Authoring and reviewing Pharmaceutical Technology procedures, development, and validation reports
Assist in the planning, prioritization, and execution of development and validation studies to support the project (i.e. technical transfer and new vaccine introduction), continuous improvement, and manufacturing assist activities related to Formulation, Filling, and Lyophilization.
Promotes Quality by Design (QbD) and Design Space. Recognized as an expert in drug product
EDUCATION AND EXPERIENCE
Ph.D. & 2-3 years of experience in the vaccine/biopharmaceutical industry
Master's degree and 5 years of experience in the vaccine/biopharmaceutical industry; or
Bachelor's degree 8 years of experience in the vaccine/biopharmaceutical industry
Demonstrated expertise in Lyophilization and Filter selection
Demonstrated expertise in the formulation of biomolecules live and inactivated viruses
Demonstrated expertise in scale down model design and qualification
Demonstrated expertise in applying risk-based approaches and QbD/DOE principles
Skilled in the transfer of early phase clinical manufacturing processes from R&D to Industrial Operations: including the writing of protocols, reports, BPRs, and technology transfer documents
Demonstrated skills in leading small technical teams
Demonstrated strong communication (oral and written), interpersonal and interdisciplinary skills.
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.