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QC Method Validation Consultant
Job Summary
A company is looking for a Validation Consultant.
Key Responsibilities
- Lead validation of release test methods for monoclonal antibody products in late-phase development
- Oversee QC Method Validation Transfer, ensuring compliance with established protocols
- Collaborate with contract test labs and troubleshoot analytical methods as needed
Required Qualifications
- Experience in QC Method Validation Transfer, specifically with method validation and transfer
- Expertise in protein purity methods such as SEC, CE-SDS, and cIEF
- Prior experience working in GMP laboratories
- Experience collaborating with CMOs and contract test labs
- Preferably holds an MS or PhD in chemistry or biochemistry
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COMPLETE JOB DESCRIPTION
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