Manufacturing Specialist 1, Drug Product Process

Support operational readiness during project phases, including site commissioning and qualification efforts. Troubleshoot process issues and act as a process subject matter expert for assigned areas. Coordinate batch planning, manage preventative maintenance, and create process templates. Own documentation updates, manage change management records, and lead investigations and continuous improvement activities. Create and update electronic and paper batch records while ensuring operations adhere to compliance and safety procedures. Assist with inspections, audits, and technology transfer activities within manufacturing. Manage projects within Drug Product Finished Goods and mentor junior associates. Flexibility with shift rotation is required to support the 24/7 manufacturing facility.