Production Technician I

Legend Biotech USA; Millburn (NJ); On-site; Full time

Job summary

A leading company in Millburn, NJ is seeking a Production Technician to actively participate in the daily production of Radioligand Therapies. The role involves adhering to regulatory requirements while executing production tasks. Candidates should have a strong background in cGMP and aseptic environments, with responsibilities including operating equipment and ensuring compliance with safety guidelines. Flexibility in shift preferences is preferred, and the position offers competitive pay and benefits.

Benefits

Medical Benefits

Financial Benefits

Qualifications

• 1+ year experience in cGMP or aseptic environment preferred.
• Ability to gown aseptically and work in a Grade C clean room.

Responsibilities

• Execute manufacturing activities for RLT products.
• Support production readiness by cleaning cells and sterilizing isolators.
• Prepare documents and records such as batch records.

Skills

cGMP regulations

Aseptic Techniques

Environmental Monitoring

Team Collaboration

Education

Bachelor’s degree in Engineering or Science

Job description

Job Description Summary

#LI-Onsite

This role is located on-site in Millburn, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Production Technicians play an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment.
The Production Technician 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. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner.

Job Description

Key Responsibilities:

• Execute all activities related to the manufacturing of RLT products, including operating and maintaining grade A isolators, focusing on KPI goals, and ensuring adherence to all state, federal, and Novartis radiation safety guidelines.
• Complete required training curriculum, including SOPs, Aseptic Techniques, Gowning Qualifications, and other relevant training such as HSE.
• Support production readiness by cleaning cells, sterilizing isolators, and conducting environmental monitoring.
• Prepare materials maintaining material identity according to batch monitoring systems.
• Ensure compliance with cGMP activities.
• Participate in qualification/validation activities, assist in deviation investigations and inspections.
• Prepare documents and records such as batch records, shipping documents, and training materials.

Shift: Sun-Wed or Wed-Sat, AM Shift - 6am-6pm (12-Hour Rotating Shifts). Flexibility on shift preference is preferred. Mandatory overtime may be required.

Essential Requirements:

• Bachelor’s degree in Engineering or Science is highly preferred; alternatively, 1+ year experience in cGMP or aseptic environment.
• Knowledge of cGMP regulations and FDA guidance for aseptic manufacturing is preferred.
• Ability to gown aseptically and work in a Grade C clean room environment for extended periods.
• Near vision acuity of 20/20, with corrective lenses permitted; no color vision impairment.
• Ability to lift or carry up to 35 pounds.
• Radio Pharma experience is preferred.

The pay range at start is expected to be between $27.79 to $51.59/hour. Salary may fluctuate during the year due to market conditions. Final salary depends on experience, skills, and location. Benefits include medical, financial, and other perks, with details provided upon offer. The position is at-will, with possible salary adjustments.

Additional Information:

• Company will not sponsor visas.
• We are committed to diversity and inclusion.
• Equal Opportunity Employer: We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or other protected statuses.
• For reasonable accommodations, contact [e-mail] or call [phone], including the job requisition number.