The Production Lead, acting under minimal supervision, will develop and lead a cohesive multi-functional work team(s) to produce a quality product in a safe and efficient manner while adhering to all compliance standards.  He/she oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly.  Directs and supports teams to execute clinical and commercial Production to meet production objectives in accordance with SOPs and cGMP requirements.