Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data. Facilitate Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data.
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 company’s Quality Management System.
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.
Amylyx is seeking an Associate Director, Drug Substance to join the CMC and External Manufacturing team, serving as the technical development drug substance owner for Avexitide and AMX-0114. This role involves working with external CDMOs to develop, scale-up, and validate drug substance processes, contributing directly to asset CMC teams and reporting to the Senior Vice President, Global CMC and External Manufacturing.