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: 12-Hour Shifts, alternating Wednesday’s. 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 bachelor's degree, a minimum of 1+ year’ of experience in cGMP or aseptic environment is required, plus high school diploma.
• 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.

Desired Requirements:

• Radio Pharma experience preferred.

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $27.77 to $51.57/hour. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.