Quality Control Raw Material Steward-Northborough,MA
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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The Quality Control Raw Material Steward will establish a continuous and integrated knowledge base and understanding of all the physical/biochemical properties of the raw materials used across the Sanofi Specialty Care network in commercial and late stage development cell culture processes. A critical aspect of the role is to ensure a "line of sight" throughout the supply chain and operational units of practices to ensure appropriate control of critical raw material attributes as they relate to process performance, product quality, stability, and yield.
The role is the focal point for the management ofknowledge (both technical and operational focused)and leading the development and maintenance of a control strategy for media raw materials across Sanofi Specialty Care biologics manufacturing network.
The raw material steward will provide overall technical leadership of raw material related continuous improvements projects that affect multiple sites, The raw material steward will play a pivotal role in providing input and context in cases of raw material changes and will also ensure that such learnings are leveraged across all manufacturing sites.
This individual will provide the interface between Quality Control Raw Materials (QCRM) and Manufacturing Science Analytical Technology (MSAT) organizations with the following responsibilities:
- Has in depth understanding of chemistry and fundamentals of raw material use in the manufacturing processes
- Understands raw material criticality with regard to product and process performance
- Develops Specification Development and Fit for Use documents for raw materials as required
- Define Critical Material Attributes of raw materials and provide alignment to testing strategies defines in specification development reports and Material Specifications
- Assesses and improves as appropriate information flow from raw material supplier
- Contributesto ongoing investigationsor technical studies around raw materials related to manufacturing and supply
- Develops impact assessments for global change controls related to raw materials
- Implements a knowledge management systemfor raw materials
- Contributes to process risk profiling efforts and identification of required corrective actions for raw materials
- Enhance technologies, processes and knowledge through provision of central services (e.g. Extractables and Leachables, Particle ID, etc)
- Develops a technical life cycle agenda around raw materials and progresses strategies
- Provides advice to the technical lead in major tech transfers involving raw materials
- Stays current on industry best practices related to raw material, process-, product-, control technology, synthetic chemistryand compendialharmonization/modernization (e.g. USP,EP, JP).
- Strong collaborative skills to build relationships and knowledge across boundaries within Sanofi network and beyond
- A Bachelor’s degree and 9+ years in a scientific discipline OR
- A Master’s degree and 7+ years' experience in a scientific discipline AND
- Experience in Quality Control or a Manufacturing Technology environment
- Detailed knowledge and/or experience with manufacturing environment in biologics operations
- Knowledge of analytical chemistry techniques and methods
- A Ph. D. and 4- 8 years’ experience
- Experience in Raw Materials on-boarding and qualifications
- An ability to share and apply knowledge in support of technical challenges
- An understanding of single use technology including fabrication and use in manufacturing
- Strong technical networker with the ability to work in a matrix environment
- Basic understanding of supplier management
Other skills the successful candidate will possess:
- Excellent interpersonal skills and a team-player
- Ability to closely collaborate and build bridges
- Excellent and effective communication 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.
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