Shift Supervisor, Weekend Days

Novartis•Indianapolis, IN

4d•$77,000 - $143,000

About The Position

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.

Requirements

3-5 year's cGMP manufacturing, cell culture/ cell therapy preferred
Proven process understanding (Pharma, cGMP, Regulatory Aspects)
Bachelors degree required or 3-5 years of relevant experience in lieu of degree
1-2 years experience in a Lead or Supervisory role required, with focus on ensuring training and process compliance during daily operations

Nice To Haves

Project management, Operational Excellence, Product/Process Development or Regulatory experience a plus.
Contribute to site Manufacturing financial/business goals
Maximize Quality and Process improvements
Minimize rejected patient lots, media, and write-offs

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.