Isotope Manufacturing Shift Supervisor, 2nd Shift

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

Job summary

Join an innovative company as an Isotope Shift Supervisor, where you'll lead a dynamic production team in delivering high-quality isotope products. Your role will involve ensuring compliance with HSE and GMP regulations while fostering a culture of continuous improvement. With a focus on operational excellence, you'll manage daily production activities, mentor associates, and drive quality enhancements. This is an exciting opportunity to contribute to a forward-thinking organization that values safety, quality, and employee development. If you're passionate about making an impact in the pharmaceutical industry, this role is perfect for you.

Benefits

401(k) eligibility

Paid time off benefits

Health insurance

Parental leave

Sign-on bonus

Restricted stock units

Qualifications

• 3-5 years of cGMP manufacturing experience required.
• 1-2 years in a Lead or Supervisory role focusing on training compliance.

Responsibilities

• Supervise daily operations of the production team ensuring quality and safety.
• Maintain an audit-ready shop floor and assist with internal audits.

Skills

Change Control

Chemical Engineering

Continual Improvement Process

Efficiency

Good Documentation Practice

Lean Manufacturing

Manufacturing Process

Risk Management

Root Cause Analysis (RCA)

Education

Bachelor's degree

3-5 years of relevant experience

Tools

SAP

LIMS

MES

Job description

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 manner. In 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 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

#LI-Onsite

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.

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 [e-mail] 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.

Salary Range

$81,200.00 - $150,800.00

Skills 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-Being