Raw Material Specialist Job
We are seeking an experienced Raw Material Specialist to join our team. In this role, you will be responsible for managing raw materials used in Biologics and Gene Therapy development projects.
Responsibilities:
* Map and Monitor Raw Materials: Identify, track, and monitor all raw materials used in our development projects.
* Risk Assessment and Mitigation: Lead risk assessments related to quality, regulatory compliance, and supply chain continuity.
* Quality by Design (QbD) Approach: Implement a QbD approach focusing on Critical Material Attributes (CMA).
* Template Development: Create templates, guidelines, and best practices for raw material management during development phases.
* Cross-Functional Collaboration: Collaborate daily with Procurement, Quality, Regulatory, and Clinical Manufacturing departments.
* Technical Alignment: Partner closely with upstream and downstream experts to ensure technical alignment.
Requirements:
* Experience: At least 5 years of experience in a biopharmaceutical environment, ideally in process development.
* Skills and Qualifications: Solid background in risk analysis, project management, and prioritization of technical activities.
* Bioprocess Expertise: Strong understanding of upstream/downstream bioprocesses. Expertise in downstream processing is a strong asset.
* Linguistic Skills: Fluent in English (written and spoken); French is a plus but not required.
Benefits:
* Attractive Salary Package: We offer a competitive salary package.
* Professional Development: Access to trainings in technical matters and soft skills.
* Career Partnership: We will be your career partner for each step along the way.