Novartis
Novartis
Posted 3 months ago
Full Time
Indianapolis, Indiana
In Person
Smart Summary
Responsibilities
Manufacture radioligand therapy products following strict aseptic discipline and batch instructions. Operate Grade A isolators and maintain production cells while ensuring compliance with radiation safety and quality standards.
Qualifications
You have experience in a cGMP or aseptic manufacturing environment and can follow FDA guidance for aseptic manufacturing. You are able to gown aseptically, work in a cleanroom, and possess strong attention to detail for accurate documentation. You also have reliable teamwork and communication skills to succeed in a fast-paced schedule.
Must Have Skills for ATS
cGMP
aseptic technique
aseptic manufacturing
current Good Manufacturing Practice
FDA guidance
Grade C cleanroom
batch records
controlled documentation
radiopharmaceutical manufacturing
Job Description
Band
Level 2Job Description Summary
#LI-OnsiteJob Description
Key Responsibilities:
· Manufacture radioligand therapy products by following batch instructions and maintaining strict aseptic discipline.
· Operate and maintain Grade A isolators to meet safety, quality, and key performance indicator targets.
· Follow radiation safety requirements and comply with all state, federal, and Novartis guidelines.
· Complete required training in Standard Operating Procedures, aseptic technique, gowning qualification, and Health, Safety, and Environment.
· Clean production cells manually and sterilize isolators to ensure production readiness.
· Perform routine and dynamic environmental monitoring per procedure and document results accurately.
· Prepare materials, maintain identity and traceability, and update the batch monitoring system as required.
· Execute work in alignment with current Good Manufacturing Practice and site quality standards.
· Support qualification and validation activities; contribute to deviation investigations and inspection readiness.
· Prepare and maintain batch records, shipping documentation, and training materials to ensure compliant operations.
Essential Requirements:
· Bachelor’s degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1+ year’ of experience in cGMP or aseptic environment is required.
· Working knowledge of current Good Manufacturing Practice for sterile or aseptic manufacturing environments.
· Ability to follow United States Food and Drug Administration guidance relevant to aseptic manufacturing.
· Ability to gown aseptically and work extended periods in a Grade C cleanroom environment.
· Strong attention to detail and ability to complete batch records and controlled documentation accurately.
· Near vision equivalent to 20/20 with no color vision impairment; corrective lenses permitted.
· Ability to lift or carry up to 35 pounds and perform hands-on production tasks.
· Reliable teamwork and communication skills to succeed in a fast-paced, shift-based schedule.
Desirable Requirements:
· Radiopharmaceutical manufacturing experience preferred, especially in aseptic or cleanroom operations.
· English proficiency for reading, writing, and speaking in a regulated manufacturing environment.
Novartis Compensation and Benefits:
The salary for this position is expected to range between $25.19/hr. and $46.83/hr.
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
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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$52,400.00 - $97,400.00Skills Desired
General Hse Knowledge , gmp knowledgeNovartis
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