Shift Supervisor, Weekend

Position Overview

The Isotope Shift Supervisor is responsible for the daily operations of the production team, directing and managing manufacturing operations to deliver high quality isotope products in a safe, compliant, efficient and cost‐effective manner. This role ensures all manufacturing operations within scope comply with HSE and GMP regulations.

Location: Indianapolis
Schedule: Weekend days, 12 hours

Key Responsibilities

• Ensure the shop floor achieves targets for Quality, Safety, and Productivity (production throughput times and batch record review).
• Lead and facilitate shop floor meetings, adjust schedules and personnel to properly staff the modules as needed.
• Maintain an "audit ready" shop floor; assist with internal pre‐audit walkthroughs, CGMP housekeeping and general organization of manufacturing spaces.
• Maintain a daily physical presence with direct reports on and off the shop floor to supervise, coach, and support.
• Ensure Associates demonstrate proper aseptic techniques and behaviors.
• Possess basic technical knowledge and background on multi‐product processes.
• Proficient in production IT systems such as SAP, LIMS, and MES.
• Responsible for training of all direct reports, including on‐time completion of required training curriculum comprised of global and local SOPs.
• Adhere to SOPs, cGMPs, and safety rules; ensure Associates execute tasks per approved policies and procedures.
• Coordinate, monitor, and improve production processes with a Quality and Continuous Improvement mindset.
• Work with the team to resolve and implement Corrective Actions and Preventative Actions (CAPAs).
• Support Associates through one-on-one discussions and periodic check-ins to achieve annual objectives and development opportunities.
• Manage disciplinary actions (including PiPs) with direct reports.
• Participate in hiring strategy.
• Compile area metrics, reports, and performance levels as required; draft and deliver reports to higher level management.

Required Qualifications

• 3-5 years of cGMP manufacturing experience; cell culture/cell therapy preferred.
• Proven process understanding (Pharma, cGMP, Regulatory Aspects).
• Project management, Operational Excellence, Product/Process Development or Regulatory experience is a plus.
• Contribute to site Manufacturing financial/business goals.
• Maximize quality and process improvements.
• Minimize rejected patient lots, media, and write-offs.
• Bachelor's degree required or 3-5 years of relevant experience in lieu of degree.
• 1-2 years of experience in a Lead or Supervisory role, with focus on ensuring training and process compliance during daily operations.

Benefits & Perks

• Benefits: Learn about all the ways we’ll help you thrive personally and professionally.