The Raw Material Scientist is a technical expert responsible for establishing and coordinating a comprehensive strategy to identify critical/key raw materials during development to support process development decision making.
He/She will support the definition of appropriate technical controls and the implementation these practices during the development of biologics and gene therapy products to improve process robustness, cost efficiency, and readiness for regulatory submissions.
Responsibilities:
- Develop expertise in raw material management.
- Implement Risk Assessments to evaluate risks related to quality, supply, and regulatory compliance.
- Create templates and mitigation plans for critical raw materials.
- Collaborate with cross-functional teams to ensure raw material integration into GMP-compliant processes.
