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Scorpion Therapeutics in Hopewell, NJ, seeks a GMP QC Chemistry (Capillary Electrophoresis) Lab Manager to lead the CE laboratory supporting biopharmaceutical manufacturing and testing.
You will establish and maintain quality systems, ensure timely testing and reporting, and support regulatory inspections, with approx. 10% travel.
Responsibilities include daily lab operations, validation, SOP management, personnel training, deviation investigations, and EHS compliance.
Manage and lead the GMP-compliant QC Chemistry (Capillary Electrophoresis) laboratory supporting biopharmaceutical manufacturing and testing. Objectives include establishing and maintaining quality systems, ensuring timely testing and reporting, and supporting regulatory inspections.
Encompass daily laboratory operations, validation, SOP management, personnel training, investigation of deviations, and ensuring EHS compliance.
Bachelor's in Chemistry, Biochemistry, or Biotechnology with 5+ years of GMP CE testing experience; Master's preferred. Management experience of 2+ years leading laboratory teams required.
Expertise in CE analytical methods (CGE, CZE, cIEF/icIEF), GMP regulations (FDA/EU), instrument validation, and quality control principles; proficiency in MS Office.
Biopharma environment, GMP compliance, capillary electrophoresis techniques, FDA/EU regulations, and support of manufacturing release testing.
Collaboration with QC teams and external audits.
Full-time at Hopewell, NJ, with approximate 10% travel.