Sr. Manager Clinical Supply Operations

Role: Senior Manager of Clinical Supply Operations supporting early-phase cell and gene therapy clinical trials, including autologous and allogeneic projects. Responsibilities: manage global supply activities such as planning, packaging, labeling, distribution, inventory reconciliation, and quality release; coordinate cross-functional efforts across sites, depots, CROs, and vendors; ensure supply chain continuity, compliance, and inspection readiness; develop demand forecasts, manage risks, and optimize operational workflows. Requirements: Bachelor's in life sciences, supply chain, or related field; 6+ years in GMP clinical supply or pharma supply chain, with experience supporting global trials, vendor management, and systems like IRT, CTMS, and eTMF. Preferred: advanced degree or clinical supply certification; background in biologics, cell/gene therapy, or temperature-sensitive products; knowledge of GMP, QA/QP release, and regulatory documentation. High-value biopharma specifics: early-stage clinical trials, cell and gene therapies, GMP compliance, global logistics, and cross-functional collaboration with Clinical Operations, CMC, QA, Regulatory, and external vendors. Location: Somerset, NJ, with potential for cross-functional coordination. The role emphasizes operational ownership, risk mitigation, and continuous process improvement in a fast-paced, innovative biotech environment.