The Clinical Supplies Room Leader Acting under direct supervision, this role executes and oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product, including blistering, bottling, carding, encapsulation, labeling, and assembly. Essential Duties and Responsibilities Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MIs) in accordance with company SOPs and cGMP regulations. Complete support documentation associated with the execution of the packaging operation(s) being performed. Ensure that packaging areas are maintained in accordance with company SOPs and cGMP regulations before, during, and after any packaging operation. Operate packaging equipment. Train Clinical Supplies Packaging Technicians on job‑specific duties. Monitor Clinical Supplies Packaging Technicians in the assigned packaging area to ensure compliance with company SOPs, manufacturing instructions, and cGMP regulations. Adhere to set safety standards. Participate actively in regular meetings. Achieve expected performance measures. Other duties as assigned. Qualifications High school diploma or GED equivalent. 1+ years of previous clinical supplies packaging or cGMP experience. Excellent oral and written communication skills. Demonstrated ability to monitor and supervise packaging operations. Ability to lead as a change agent, handle multiple tasks simultaneously, and negotiate and meet critical timelines. Responsible for cleaning of cGMP packaging areas, equipment, and utensils on an as‑needed basis. #J-18808-Ljbffr