Senior Project Manager - Associate Director, CMC

Role: Project Manager overseeing outsourced manufacturing and testing programs for CLD-401 in a clinical-stage immuno-oncology setting. Primary objectives include managing CMC activities, coordinating technical transfer, and ensuring IND-enabling milestones are met. Responsibilities encompass vendor management, project planning, documentation review, risk mitigation, and cross-functional collaboration with Quality Control, Manufacturing, Regulatory, and Process Development teams. The role involves overseeing analytical and process development activities, tracking progress, and supporting regulatory submissions. Qualifications: BS or higher in Life Sciences, Chemistry, or related field; 5+ years of experience, preferably PMP certified; familiarity with GxP environments, CGMP, GCP, GLP, and external testing oversight. High-value specifics include experience supporting biologics or gene therapies in CGMP settings, managing outsourced analytical testing, and coordinating with CDMOs. The position requires strong organizational, communication, and project management skills, with occasional travel to vendor sites. Work setup: based in San Diego, California.