Associate Director, Assay and Process Development

Role: Associate Director of Assay and Process Development leading cellular and molecular testing for preclinical bioproducts, reporting to the CSO. Responsibilities: oversee team of scientists/engineers; develop and validate high-complexity biochemistry and cell biology assays; create test quality and performance specifications; design and analyze experiments (e.g., DOE, statistical modeling); establish scalable processes from conception to validation; ensure compliance with GLP, QA/QC, and safety standards; collaborate with R&D, Oncology investigators, and quality teams; support preclinical documentation and clinical study preparations. Requirements: PhD/MS in (bio)engineering or related field; extensive leadership and hands-on experience in process development and high-complexity assay creation; proven expertise in molecular assays, statistical analyses, and process validation; strong technical skills in laboratory systems, data analysis software (JMP, R, MATLAB), and design tools. Preferred: experience with cellular and molecular testing in biopharma; knowledge of GLP regulations; prior involvement in preclinical development for oncology or immunology indications. HighValue: leadership in cell-based assay development, process scale-up, GLP compliance, preclinical documentation, and collaboration with oncology research. WorkSetup: laboratory environment, standard hours, with flexibility; supervisory role for 1–5 staff.