Production Lead Operator

Aug 20, 2021

Job Description

769 million. That’s how many lives are touched by Novartis products globally. And, while we’re proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people’s lives?

Your responsibilities include, but are not limited to:

• Supports Production Manager in all planning, coordinating, and execution of Production activities. Primary contact for technical troubleshooting and compliance-related matters.
• Supervises and supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators using vaporized hydrogen peroxide. Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure. Acts as Subject Matter Expert in his or her area of expertise: primary contact for troubleshooting, deviation/OOS investigations, assess product and environmental data and performs trending, and production documentation management.
• Participation in assigned qualification/validation activities, as necessary
• Responsible for successful on time completion of required training curriculum comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role. Liaise with Quality Assurance on an on-going basis to ensure compliance activities are performed in a timely manner.
• Coaches operators on the shift to ensure on-boarding and training is consistently followed.
• Ability to make key decisions regarding production processes in the absence of the Production Manager.
• Facilitates a culture of “speaking up” and ensuring all cGMP compliance activities are followed. Promote and improve the Safety and Quality cultures
• Prepares applicable documents and records such as batch records, shipping documents, and training materials.
• Promote continuous improvement in the production lines and all general GMP areas.
• Acts as SME for any applicable audits and inspections as required. Represent production management to the team members and promote Novartis values within the
Team. Suggest improvement actions (organization, process, safety, hygiene, etc.) at shop floor.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:

Associates degree or higher in STEM field or equivalent military or pharmaceutical manufacturing qualifications
5 years’ experience in the manufacturing of pharmaceutical drug products, preferably parenteral or radiopharmacy operations. Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing preferred. General HSE Knowledge (radiation safety practices are an advantage)
Knowledge of cGMP manufacturing or laboratory environment

Why Advanced Accelerator Applications (AAA)?

Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications (AAA), a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Indianapolis, IN
Technical Operations
Full Time
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Production Lead Operator

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