Senior Analyst, QC Chemistry

Role: Senior QC Chemist supporting GMP manufacturing of biopharmaceuticals, primarily in large molecule production, ensuring compliance with FDA/EU regulations. Responsibilities: perform routine/non-routine testing using HPLC, UPLC, UV-Vis, and electrophoresis; review and report data; investigate OOS events; support method validation and transfer; maintain equipment and reagents; participate in audits and training; serve as subject matter expert in analytical testing. Requirements: Bachelor's or higher in Chemistry, Biochemistry, or Biotechnology; 4+ years in FDA-regulated biopharma; hands-on experience with analytical techniques (HPLC, UPLC, GC, UV, FTIR); knowledge of GMP, USP/EP, and instrument validation; proficiency with chromatography data systems (Waters Empower); strong problem-solving, attention to detail, and communication skills. Preferred: leadership experience, familiarity with GMP audits, and proven track record in QC within biotech/pharma. High-Value: GMP compliance, QC testing for biologics, method validation, regulatory audits, and cross-functional collaboration. WorkSetup: full-time at Hopewell, NJ; travel approx. 10%.