Manager, Quality Control Chemistry

Role: 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. Responsibilities encompass daily laboratory operations, validation, SOP management, personnel training, investigation of deviations, and ensuring EHS compliance. Qualifications: 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. Skills: expertise in CE analytical methods (CGE, CZE, cIEF/icIEF), GMP regulations (FDA/EU), instrument validation, and quality control principles; proficiency in MS Office. High-value specifics: biopharma environment, GMP compliance, capillary electrophoresis techniques, FDA/EU regulations, and support of manufacturing release testing. Collaboration with QC teams and external audits. Location: full-time at Hopewell, NJ, with approximate 10% travel.