Manager, QC Biochemistry (Hopewell, NJ)
BeOne Medicines(1 month ago)
About this role
The QC Biochemistry Manager at BeOne oversees the quality control biochemistry laboratory supporting GMP manufacturing, testing, and release of biopharmaceutical materials under FDA/EU regulations. The role is focused on maintaining regulatory compliance, establishing laboratory procedures and quality systems, and ensuring the lab meets organizational performance targets. This position works closely with cross-functional teams and supports regulatory inspections and audits.
Required Skills
- Biochemistry
- Potency Assays
- Binding ELISA
- Cell Culture
- Residual DNA
- HCP Assays
- Method Validation
- Equipment Validation
- GMP
- SOPs
+4 more
Qualifications
- Bachelor's Degree in Chemistry, Biochemistry or Biotechnology
- Master's Degree Preferred
About BeOne Medicines
beonemedicines.comBeOne Medicines, formerly BeiGene, is committed to developing innovative cancer medicines by partnering globally to serve patients everywhere.
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