Novartis
Production Lead, Weekend Nights
Summary : Production Leads play an active role in daily production of isotope manufacturing, set up and prepare instruments and equipment. They adhere to regulatory requirements while executing production per batch records and SOPs. Responsibilities are performed within a team according to assigned shift schedule. Production Leads work closely with the Shift Supervisor and Production Manager to ensure production is safe and timely.
Major accountabilities:
Execute activities related to manufacturing of RLT isotope products, operating and maintaining grade C isolators, focusing on KPI goals and ensuring adherence to state, federal and Novartis radiation safety guidelines.
Responsible for successful completion of required training curriculum comprising SOPs, techniques, gowning qualifications and other relevant training including HSE for the role.
Support technical aspects of production readiness including manual cleaning of the cell and sterilization of isolators.
Conduct routine and dynamic environmental monitoring as required.
Prepare all materials while maintaining material identity in accordance with batch monitoring system.
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, training materials.
Participate in periodic mandatory overtime to ensure process continuity and completion.
Ensure technicians complete all required training per published curriculum.
Participate in technicians' professional development counselling to foster a growth culture.
Other duties as assigned.
Minimum Requirements:
Bachelor of Science preferred; if no degree, a minimum of 2 years experience in a cGMP or aseptic environment can substitute.
Training in radiochemistry or radiopharmacy preferred.
4+ years experience in pharmaceutical manufacturing, low bioburden manufacturing preferred.
Good understanding of manufacturing and validation requirements and activities.
Capable of exploiting new technology and techniques to eliminate non‑value adding activities and improve productivity.
Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
Flexibility to don clean room garments and PPE.
Near vision 20/20, color vision no impairment; corrective lenses allowed.
Prohibition of makeup, jewelry, nail polish, perfume/cologne and other microbial sources in restricted areas.
Ability to lift or carry up to 35 pounds.
Shift:
Weekend days, 12 hours
Location:
Indianapolis, IN
Salary:
$103,844.00 – $168,747.00
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 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: 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 email to [email protected] or call +1 877 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Major accountabilities:
Execute activities related to manufacturing of RLT isotope products, operating and maintaining grade C isolators, focusing on KPI goals and ensuring adherence to state, federal and Novartis radiation safety guidelines.
Responsible for successful completion of required training curriculum comprising SOPs, techniques, gowning qualifications and other relevant training including HSE for the role.
Support technical aspects of production readiness including manual cleaning of the cell and sterilization of isolators.
Conduct routine and dynamic environmental monitoring as required.
Prepare all materials while maintaining material identity in accordance with batch monitoring system.
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, training materials.
Participate in periodic mandatory overtime to ensure process continuity and completion.
Ensure technicians complete all required training per published curriculum.
Participate in technicians' professional development counselling to foster a growth culture.
Other duties as assigned.
Minimum Requirements:
Bachelor of Science preferred; if no degree, a minimum of 2 years experience in a cGMP or aseptic environment can substitute.
Training in radiochemistry or radiopharmacy preferred.
4+ years experience in pharmaceutical manufacturing, low bioburden manufacturing preferred.
Good understanding of manufacturing and validation requirements and activities.
Capable of exploiting new technology and techniques to eliminate non‑value adding activities and improve productivity.
Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
Flexibility to don clean room garments and PPE.
Near vision 20/20, color vision no impairment; corrective lenses allowed.
Prohibition of makeup, jewelry, nail polish, perfume/cologne and other microbial sources in restricted areas.
Ability to lift or carry up to 35 pounds.
Shift:
Weekend days, 12 hours
Location:
Indianapolis, IN
Salary:
$103,844.00 – $168,747.00
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 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: 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 email to [email protected] or call +1 877 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
#J-18808-Ljbffr