Isotope Manufacturing Shift Supervisor, 2nd Shift

Novartis; Indianapolis (IN); On-site; USD 81,000 - 151,000; Full time

Job summary

An established industry player is seeking a dedicated Isotope Manufacturing Shift Supervisor to oversee the daily operations of their production team. This pivotal role focuses on ensuring the delivery of high-quality isotope products while adhering to stringent safety and compliance standards. You will lead a dynamic team, facilitate shop floor meetings, and maintain an audit-ready environment. If you have a background in cGMP manufacturing and a passion for operational excellence, this is an exciting opportunity to make a significant impact in a collaborative and innovative setting.

Qualifications

• 3-5 years experience in cGMP manufacturing, preferably in cell culture.
• Proven understanding of pharma and regulatory aspects.

Responsibilities

• Lead daily operations of the production team ensuring quality and compliance.
• Supervise and coach associates on proper aseptic techniques.

Skills

cGMP manufacturing

cell culture

project management

operational excellence

process compliance

Education

Bachelor's degree

3-5 years of relevant experience

Tools

SAP

LIMS

MES

Job description

Isotope Manufacturing Shift Supervisor, 2nd Shift

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Isotope Manufacturing Shift Supervisor, 2nd Shift

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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.

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.

About The Role

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 year's 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
• On-site role, AM Shift
• 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
  
  

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

The pay range for this position at commencement of employment is expected to be between $81,200 to $150,800 per annum; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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 & 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 [email protected] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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