Shift Supervisor, Weekend Days

Role Summary

The Isotope Shift Supervisor is responsible for the daily operations of the production team, specifically the direction and management of manufacturing operations to deliver high quality isotope products in a safe, compliant, efficient and cost-effective manner. In addition, successful execution of this role ensures all manufacturing operations within scope occur in compliance with both HSE and GMP regulations.

Responsibilities

• Ensures the Shop Floor achieves targets for Quality, Safety, and Productivity (Production throughput times and batch record review).
• Lead and facilitate shop floor meetings, making schedule and personnel adjustments as necessary to properly staff the modules.
• 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 are demonstrating the proper aseptic techniques & behaviors.
• Possess basic technical knowledge and background on multi product processes.
• Proficient in the use of production related IT systems such as SAP, LIMS, and MES.
• Responsible for training of all direct reports, including the on-time completion of required training curriculum comprised of global and local SOPs.
• Adhere to all SOPs, cGMPS, and safety rules and regulations; ensure Associates are executing tasks per approved policies and applicable procedures.
• Coordinate, monitor, and improve, production process with a Quality and Continuous improvement mindset.
• Work with team to resolve and implement Corrective Actions and Preventative Actions (CAPAs).
• Support Associates throughout the year during one-on-one discussions and periodic check-ins to achieve annual objectives and development opportunities.
• Manage any 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.

Qualifications

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

Education

• Bachelor's degree required or 3-5 years of relevant experience in lieu of degree