Job Description

Summary

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy (RLT) to cancer patients.

As a Packaging Manufacturing Specialist, you will play an active role in daily production of Radioligand Therapy products. You will be responsible for overseeing the packaging process on the production/packaging lines and ensuring that products are packaged accurately and efficiently. The Packaging Manufacturing Specialist adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. This role involves monitoring packaging materials, managing equipment, troubleshooting packaging issues, and collaborating with Quality Assurance Batch Review, Supply Chain and Manufacturing to optimize operations.

Shift: This position follows a 12-hour rotating shift schedule: Thursday-Sunday from 6:00pm to 6:00am one week and Friday-Sunday from 6:00pm to 6:00am the next week. Shift work including weekends is required, and there may be potential for overtime.

About the Role

Key Responsibilities:

• Responsible for successful on-time completion of required training curriculum comprised of the necessary Standard Operating Procedures (SOPs), Gowning Qualifications and other relevant training including Health, Safety & Environment (HSE) requirements for the specific role.
• Execute all activities related to the packaging/manufacturing of RLT products. Responsibilities include monitoring operations to ensure smooth production flow from manufacturing to packaging to shipping; focusing on KPI goals, cGMP compliance activities, and ensuring all state, federal and Novartis radiation safety guidelines are followed.
• Complete supporting documentation associated with the execution of operations (labeling, inspection, attachment generation, etc.) being performed in accordance with good documentation practices.
• Prepares/check in materials while maintaining material identity in accordance with the batch monitoring system as defined by procedure.
• Coordinate with Supply Chain Technicians to ensure in-stock conditions on materials.
• Assist with Post-Lead Pot Unloading activities, label verification, Pre/Post CCIT, delivery/submission of QC samples.
• Participate in continuous improvement initiatives to optimize packaging/manufacturing operations.
• Collaborate with Quality Assurance team to investigate and resolve quality concerns related to packaging.
• Participate in assigned qualification/validation activities, and assist on deviation investigations and inspections, as necessary.
• Contribute to the development and maintenance of applicable documents and records such as batch records, standard operating procedures, logbooks, shipping documents, and training materials.

Essential Requirements:

• High school diploma or equivalent with a minimum of 2 years of experience in a packaging or manufacturing environment.
• Strong understanding of packaging materials, equipment and processes.
• Proficiency in quality control procedures and troubleshooting skills.
• 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

Desirable Requirements:

• Radio Pharma experience preferred.

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: novartis-life-handbook.pdf .

The pay range for this position at commencement of employment is expected to be between $22.83 and $42.45 per hour.

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.

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