Job Description 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 addition successful execution of this role ensures all manufacturing operations within scope occur in compliance with both HSE and GMP regulations.Job Description
Major accountabilities:
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.
Essential Requirements:
3-5 years cGMP manufacturing cell culture/ cell therapy preferred
Proven process understanding (Pharma cGMP Regulatory Aspects)
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
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
Shift: Weekend days 12 hours
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion sex national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$77000.00 - $143000.00Skills Desired
Change Control Chemical Engineering Continual Improvement Process Efficiency Employment Discrimination Flexibility General Hse Knowledge Good Documentation Practice Knowledge Of Capa Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Physics Process Control Production Line Productivity Risk Management Root Cause Analysis (RCA) Scheduler Technology Transfer Well-BeingRequired Experience:
Manager
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.