Packaging Manufacturing Specialist

Novartis Group Companies; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

An innovative company in the field of nuclear medicine is seeking a Packaging Manufacturing Specialist to join their team. In this role, you will be integral to the production of Radioligand Therapy products, ensuring that all packaging processes are executed with precision and in compliance with regulatory standards. You will collaborate with various teams to enhance operations and participate in continuous improvement initiatives. This position is perfect for someone with a strong background in packaging and manufacturing, looking to contribute to cutting-edge cancer treatment solutions. If you are ready to make a meaningful impact, this opportunity is for you.

Benefits

Comprehensive Health Plans

Bonuses

Stock Units

Qualifications

• At least 2 years of experience in packaging or manufacturing.
• Strong knowledge of packaging materials and processes.

Responsibilities

• Oversee packaging process for Radioligand Therapy products.
• Document operations accurately and ensure compliance with cGMP.

Skills

Packaging Processes

Quality Control

Troubleshooting

Regulatory Compliance

Education

High School Diploma

Tools

Packaging Equipment

Job description

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 the daily production of Radioligand Therapy products. Your responsibilities include overseeing the packaging process on production/packaging lines, ensuring products are packaged accurately and efficiently, adhering to regulatory requirements, executing production according to batch records and SOPs, and collaborating with Quality Assurance, Supply Chain, and Manufacturing teams to optimize operations.

Shift: This role involves a 12-hour rotating shift schedule: Thursday-Sunday from 6:00 pm to 6:00 am one week, and Friday-Sunday from 6:00 pm to 6:00 am the following week. Shift work including weekends is required, with potential overtime.

Key Responsibilities:

1. Complete required training on SOPs, Gowning Qualifications, and Health, Safety & Environment (HSE) standards.
2. Perform all packaging and manufacturing activities for RLT products, ensuring smooth production flow and compliance with cGMP and radiation safety guidelines.
3. Document operations accurately, including labeling and inspection activities, following good documentation practices.
4. Manage materials, ensuring proper identification and stock levels in coordination with Supply Chain Technicians.
5. Assist with activities such as Post-Lead Pot Unloading, label verification, and QC sample submission.
6. Participate in continuous improvement initiatives to optimize packaging and manufacturing processes.
7. Work with Quality Assurance to investigate and resolve quality issues.
8. Participate in qualification/validation activities and assist with deviation investigations.
9. Maintain documentation such as batch records, SOPs, logbooks, and training materials.

Essential Requirements:

1. High school diploma or equivalent with at least 2 years of experience in packaging or manufacturing.
2. Strong knowledge of packaging materials, equipment, and processes.
3. Proficiency in quality control and troubleshooting.
4. Near vision of 20/20 (corrected vision permitted) and no color vision impairment.
5. Ability to lift up to 35 pounds.

Desirable Requirements:

• Experience in Radio Pharma is preferred.

Additional Information:

The salary range at start of employment is approximately $22.83 to $42.45 per hour, subject to adjustments based on market and individual factors. The position may include benefits such as bonuses, stock units, and comprehensive health plans. This is an at-will employment position with potential modifications to salary and benefits.

EEO Statement: We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, veteran or marital status, disability, or other protected classes.

Accessibility: We provide reasonable accommodations for individuals with disabilities. Contact us at [e-mail] or [phone] with your request and job requisition number.