Production Lead, Isotopes (3rd shift)

Novartis Group Companies; Indianapolis (IN); Sur place; USD 57 000 - 105 000; Plein temps

Résumé du poste

Novartis Group Companies in Indianapolis, Indiana is seeking a Production Lead, Isotopes to oversee daily manufacturing and mentor technicians. You will ensure GMP compliance, radiation safety, and on-time delivery of isotope products in a hands-on role.

This 3rd shift position (10 pm–6 am, Mon–Fri) requires a strong manufacturing background, ability to lead teams, and a commitment to quality. Relocation support is not available; candidates must be able to work in a controlled cleanroom

Qualifications

• Bachelor of Science strongly preferred; without a degree, a minimum of 2 years in a cGMP or aseptic environment may substitute.
• 4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing experience preferred.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.
• Ability to lift or carry up to 35 pounds.
• Ability to wear cleanroom garments and respiratory protection equipment as required.

Responsabilités

• Execute manufacturing activities for Radioligand Therapy isotope products while meeting production, quality, and radiation safety requirements.
• Operate and maintain Grade C isolators in accordance with procedures and safety requirements.
• Support production readiness through equipment prep, cell cleaning, isolator sterilization, and environmental monitoring.
• Prepare materials while maintaining material identity and following batch monitoring procedures.
• Complete batch records, shipping documents, training materials, and other documentation accurately and compliantly.
• Support qualification and validation activities while promoting GMP compliance and a speak-up culture.
• Ensure technicians complete required training and support their professional development.

Connaissances

GMP compliance knowledge

Radiation safety awareness

Team leadership

Formation

Bachelor of Science preferred

Outils

MS Office

Description du poste

Job Description Summary

Location: Indianapolis, Indiana

Relocation Support: This role is based in Indianapolis, Indiana. Novartis is unable to offer relocation support: please only apply if accessible.

Bring your manufacturing expertise to a role where quality, precision, and teamwork directly support the delivery of isotope products. As a Production Lead, Isotopes, you will play a hands-on role in daily manufacturing while helping guide and develop production technicians, maintain production readiness, and ensure activities are completed safely, on time, and in accordance with current Good Manufacturing Practice and radiation safety requirements. You'll work closely with production leadership and cross-functional partners to promote operational excellence, a strong quality culture, and continuous improvement across the manufacturing environment.

NOTE: This is a 3rd shift role. Hours are expected to be 10 pm - 6 am, Monday - Friday. Shift schedules may change based on business need.

Job Description

Key Responsibilities

• Execute manufacturing activities for Radioligand Therapy isotope products while meeting production, quality, and radiation safety requirements.
• Operate and maintain Grade C isolators in accordance with established procedures and applicable safety requirements.
• Support production readiness through equipment preparation, cell cleaning, isolator sterilization, and environmental monitoring.
• Prepare materials while maintaining material identity and following established batch monitoring procedures.
• Complete batch records, shipping documents, training materials, and other required production documentation accurately and compliantly.
• Support qualification and validation activities while promoting current GMP compliance and a speak-up culture.
• Ensure technicians complete required training and support their professional development to foster a strong growth culture.

Essential Requirements

• Bachelor of Science strongly preferred; without a degree, a minimum of 2 years of experience in a cGMP or aseptic environment may substitute.
• 4+ years of experience in pharmaceutical manufacturing, with low bioburden manufacturing experience preferred.
• Strong understanding of manufacturing and validation requirements and activities.
• Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
• Proficient in MS Office applications.
• Ability to lift or carry up to 35 pounds.
• Ability to wear cleanroom garments, personal protective equipment, and respiratory protection equipment, including PAPR and respirators.
• Ability to maintain required respiratory protection qualifications, including medical clearance, fit testing, and training, and perform manufacturing activities while wearing respiratory protection equipment for extended periods.

Desirable Requirements

• Experience or training in radiochemistry or radiopharmacy.

Salary Information

The salary for this position is expected to range between $41.05 and $76.25 per hour. 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. The 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.

Salary Range

$85,400.00 - $158,600.00

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.

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 to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

• Data Analytics