This role provides leadership, direction, and Quality Assurance (QA) oversight of contract manufacturers (CMOs) and service providers for cell bank, drug substance (DS), drug product (DP), packaging and labeling, and distribution of multiple products. The Sr. Director collaborates closely with CMC, Quality Compliance and Analytical Development colleagues to ensure compliance with all relevant cGMP regulations and guidelines as they pertain to manufacturing and supply operations, and ensures staff execute within the companyβs Quality Management System.
Job listings
$255,000β$275,000
USD/year
$165,000β$185,000
USD/year
The Senior Clinical Trial Manager (Sr CTM) will lead the operational delivery of one or more cell therapy clinical trials from study design through close-out. Sr. CTM will be accountable for timelines, budget, quality, vendor & CRO oversight, and cross-functional coordination for the assigned studies. This role requires deep knowledge of clinical operations plus specific experience in cellular therapies or advanced biologics.