Manufacturing Specialist; weekend night shift

Summary
This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Shift: Weekend Nights - position may involve mandatory overtime as needed.

About the Role

As a Manufacturing Specialist you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and be the first point of contact for product and process related issues. You will drive investigations to identify root cause and implement corrective and preventive actions.

• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing and reviewing to support manufacturing operations including SOPs, batch records, and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
• Author and own investigations related to material transfer, isotope manufacturing, and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and new technology introduction for continued productivity improvement.
• Review validation protocols and reports, support execution of process validations, and short-term improvement projects.
• Provide guidance and support to the production team through training and knowledge sharing.
• Demonstrate leadership capabilities and guide processes to closure/completion, following all required guidelines and procedures.
• Participate in assigned qualification/validation activities, as necessary.
• Facilitate a culture of “speaking up” and ensure all cGMP compliance activities are followed.
• Prepare applicable documents and records such as batch records, shipping documents, and training materials.
• Participate in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned, as necessary.
• Ensure overall inspection readiness for area of responsibility; report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt; distribute marketing samples where applicable.

• Bachelor’s degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience.
• Training in radiochemistry or radiopharmacy is preferred.
• 3+ years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
• Strong awareness of quality issues; compliance investigations experience required.
• Good understanding of manufacturing and validation requirements and activities.
• Ability to exploit new technology and techniques to eliminate non-value adding activities and improve productivity and performance through new processes.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.

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?

Benefits and Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

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 reasonab or call  and let us know the nature of your request and your contact information.

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