About the Role

Key Responsibilities:

• Executes all activities related to the manufacturing of RLT products. Responsibilities include operating and maintaining grade A isolators, focusing on KPI goals as well as ensuring all state, federal and Novartis radiation safety guidelines are adhered to.
• 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.
• Supports all technical aspects related to production readiness including manually cleaning the cell and performing sterilization of the isolators. Conducts routine and dynamic environmental monitoring as required.
• Prepares all materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Ensures all cGMP compliance activities are followed.
• Participation in assigned qualification/validation activities, and assist on deviation investigations and inspections, as necessary.
• Prepares applicable documents and records such as batch records, shipping documents, and training materials.

Shift: The shift for this role is Wednesday - Saturday (2pm - 1230am). This position may involve mandatory overtime as needed.

Essential Requirements:

• Bachelor's degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1+ year' of experience in cGMP or aseptic environment is required.
• Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred.
• Ability to gown aseptically and work in a clean room environment (Grade C) area for extended periods of time is required.
• Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
• Ability to lift or carry up to 35 pounds.
• Radio Pharma experience preferred.

The pay range for this position at commencement of employment is expected to be between $28.78 to $43.22/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.

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

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? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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 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.

Division
Operations

Business Unit
Innovative Medicines

Location
USA

Site
Millburn

Company / Legal Entity
U469 (FCRS = US469) AAA USA Inc.

Functional Area
Technical Operations

Job Type
Full time

Employment Type
Regular

Shift Work
No