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QC Lead, Formulation Development
2 weeks ago
Job Description
We are seeking an experienced QC Lead to join our Formulation Development team at AGC Biologics. In this role, you will be responsible for supporting the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.
Main Tasks
- Raw material specification development and review.
- cGMP compliant document creation and analytical result delivery.
- Risk assessment promotion and qualification protocol/report creation.
- Sampling oversight, both internal and outsourced testing.
Requirements
- MSc or PhD degree in Chemistry, Pharmaceutical Sciences, or relevant area.
- Work experience within quality control or quality assurance.
- Excellent communication and problem-solving skills.
- Ability to work in a fast-paced environment.
- Contract manufacturing experience and business understanding.
- Audit and inspection representation.
