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:  Thursday - Sunday one week, Friday - Sunday the following week, 6:00pm-6:00am.  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 $28.37 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.

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:  http://www.novartis.com/careers/benefits-rewards