Sommario
As the Production Technician, you will play an active role in daily production of radioactive isotopes as well as setup and preparation of instruments and equipment. You will adhere to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Your responsibilities will be performed within a team and according to an assigned production shift schedule. You will work closely with the Production Lead and Manager to ensure production is executed in a safe and timely manner.
NOTE: This role will support our new Isotopes Manufacturing facility. Shift hours and schedule will evolve as we move from start up to business as usual.
About the Role
Key responsibilities:
- Execute all activities related to the manufacturing of radioligand therapy (RLT) isotope products, including operating and maintaining grade C isolators, focusing on KPI goals and ensuring adherence to all state, federal and Novartis radiation safety guidelines.
- Successful on time completion of required training curriculum comprising necessary Standard Operating Procedures (SOPs) and Techniques, Gowning Qualifications and other relevant training including role-specific Health, Safety & Environment training.
- Support all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators.
- Conduct routine and dynamic environmental monitoring as required.
- Prepare all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
- Participate in assigned qualification/validation activities.
- Facilitate a “speak up” culture. Ensure all cGMP compliance activities are followed.
- Prepares applicable documents and records such as batch records, shipping documents, and training materials.
- Participates in periodic mandatory overtime to ensure process continuity and completion.
Essential Requirements:
- Bachelor of Science degree is strongly preferred. In lieu of degree, a minimum of 2 years of experience in a cGMP or aseptic environment can be substituted.
- 2+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing preferred.
- Good understanding of manufacturing and validation requirements and activities
- Ability to utilize new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes.
- Proficient in MS Office applications.
Desirable Requirements:
- Training in radiochemistry or radio pharmacy is preferred.
- Knowledge of cGMP regulations and FDA guidance applicable to radioligand therapy or isotope manufacturing.
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Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
The pay range for this position at commencement of employment is expected to be between $27.40 and $43.22 per hour; however, while salary ranges are effective from 1/1/24 through 12/31/24 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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
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 +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.