Production Technician II

Novartis Group Companies; California, Carlsbad (MO, CA); On-site; USD 57,000 - 108,000; Full time

Job summary

An innovative company is seeking dedicated Production Technicians to join their new manufacturing site. This role involves active participation in the production of Radioligand Therapies, ensuring compliance with safety and regulatory standards. Candidates will execute various manufacturing activities, maintain equipment, and uphold a culture of compliance. The position offers a dynamic work environment with opportunities for personal and professional development. Join a team committed to delivering cutting-edge therapies to cancer patients and make a meaningful impact in the field of nuclear medicine.

Benefits

Personal and professional development opportunities

Bonuses

Stock units

Health benefits

Qualifications

• Bachelor of Science preferred or 2 years' experience in a cGMP or aseptic environment.
• Knowledge of cGMP regulations and FDA guidance pertinent to aseptic manufacturing.

Responsibilities

• Execute all activities related to the manufacturing of RLT products.
• Complete required training on SOPs, aseptic techniques, and safety compliance.
• Prepare documentation such as batch records and shipping documents.

Skills

Assembly Language

Cooperation

Efficiency

Electronic Components

Flexibility

Good Documentation Practice

Installations (Computer Programs)

ISO Standards

GMP Knowledge

Lean Manufacturing

Manufacturing Processes

Nuclear Medicine

Physics

Product Distribution

Production Line

Scheduling

Education

Bachelor of Science

2 years' experience in cGMP or aseptic environment

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. We are looking for dedicated and enthusiastic professionals to join our new manufacturing site in Carlsbad!

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.

Shift: The shift schedule will be phased in as the site approaches go-live. We are planning for 12-hour rotating shifts which will include at least one weekend day.

Job Responsibilities

1. 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 safety guidelines.
2. Complete required training on SOPs, aseptic techniques, gowning, and other relevant safety and compliance areas.
3. Support technical aspects of production readiness, including cleaning and sterilization of isolators.
4. Conduct environmental monitoring as required.
5. Prepare materials maintaining proper material identity and batch monitoring.
6. Promote a culture of compliance and speaking up regarding cGMP activities.
7. Prepare documentation such as batch records, shipping documents, and training materials.
8. Be prepared for unplanned overtime to ensure process continuity.

Minimum Requirements

• Bachelor of Science preferred; if not, a minimum of 2 years' experience in a cGMP or aseptic environment is required.
• External candidates: 2+ years in aseptic pharmaceutical manufacturing, preferably in drug product filling.
• Current Novartis associates: Must have at least 12 months as a Production Technician with prior RLT experience and qualification in two critical isolator tasks.
• Knowledge of cGMP regulations and FDA guidance pertinent to aseptic manufacturing.
• Proficiency in MS Office applications.
• Flexibility to wear clean room garments and PPE.
• Near vision of 20/20 without color vision impairment; corrective lenses permitted.
• No makeup, jewelry, nail polish, perfume in restricted areas.
• Ability to lift up to 35 pounds.

#LI-Onsite

Benefits include personal and professional development opportunities. Learn more at https://www.novartis.com/careers/benefits-rewards.

The starting pay range is estimated between $27.78 to $51.58 per hour, subject to adjustments based on market conditions, experience, and location. Compensation may include bonuses, stock units, and other benefits. Final salary decisions depend on various factors.

EEO Statement:

We are Equal Opportunity Employers and 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.

Accessibility and Accommodations

If you require accommodations during the application process or to perform job functions, contact us at [e-mail] or call [phone], including your job requisition number.

Salary Range

$57,800.00 - $107,300.00

Skills Desired

Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, Good Documentation Practice, Installations (Computer Programs), ISO Standards, GMP Knowledge, Lean Manufacturing, Manufacturing Processes, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduling.