Material Science Leader – Msat
Company | Sanofi |
---|---|
Location | Framingham, MA, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | |
Experience Level | Senior, Expert or higher |
Requirements
- Lead the development of key quality attributes of most critical raw materials used in Sanofi’s commercial biologics portfolio.
- Facilitate the use of key quality attributes of the critical raw materials for raw material control and investigations.
- Drive through partnerships within MSAT the use of data analytics for raw material analysis that includes but is not limited to statistical process control / control charts for CoA attributes, correlation between raw material attributes and process performance etc.
- Take a lead in understanding, addressing and mitigating raw material-driven manufacturing deviations.
- Establish best practices to manage process performance variability owing to raw materials.
- Scientific SME on the communications with raw material suppliers for new raw material introduction and custom raw material design during biologics lifecycle process development.
- Maintain awareness on global pharmacopeia updates and their impact to Sanofi’s portfolio.
- Participate as the bioprocess SME to develop the scientific strategy for managing the impact of the pharmacopeia updates.
- Guide BioDev on best practices for raw material selection during process development.
- Be an active participant through external engagement to present Sanofi’s position and promote Sanofi’s interests.
- Consult QC RM in developing a risk-based periodic material assessment strategy to confirm compliance of the raw materials with the CoA and previously qualified state.
Responsibilities
-
No responsibilities provided.
Preferred Qualifications
-
No preferred qualifications provided.