Specialist, Quality Control Analytical

Specialist, Quality Control Analytical will provide testing support for fusion proteins, cell therapies and cancer vaccines, including wet chemistry, HPLC, Capillary Electrophoresis, UV-Vis, and ELISA. The role encompasses in-process testing, suitability-for-use testing, method development, optimizations, investigations, and complex troubleshooting. Responsibilities include creating testing protocols and reports, performing lab maintenance, supporting quality systems and documentation (change controls, SOPs, and test method updates), and handling ad-hoc cross-functional projects. Requires a Bachelor’s degree in Biochemistry or related discipline with 4+ years of biotech experience or a Master’s degree with 2+ years, with hands-on experience in HPLC and ELISA preferred; familiarity with cGMP, FDA/USP regulations, and standard QC testing practices. On-site (Dunkirk, NY) with a flexible, collaborative, goal-oriented team environment; strong communication, organizational, and problem-solving skills are essential.