Production Lead, Isotopes (3rd shift)

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 57,000 - 105,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Equity/annual incentive eligibility

Job summary

Novartis in Indianapolis, IN, seeks a Production Lead, Isotopes, to lead hands-on manufacturing of Radioligand Therapy isotope products, mentor technicians, and uphold cGMP and radiation safety standards.

Requires 4+ years pharma manufacturing, BS preferred (or 2 years in cGMP acceptable), strong manufacturing and validation knowledge, ability to lift 35 lbs, wear PPE and respiratory protection, and willingness to work 3rd shift (10 pm–6 am).

Qualifications

• BS strongly preferred; if no degree, 2+ years in cGMP/aseptic environment accepted.
• 4+ years in pharmaceutical manufacturing; low bioburden experience preferred.
• Strong understanding of manufacturing, validation, cGMP, and FDA guidance for isotope production.
• Proficient with MS Office applications.

Responsibilities

• Execute manufacturing activities for isotope products while meeting production, quality, and safety requirements.
• Operate and maintain Grade C isolators per procedures and safety requirements.
• Support readiness through equipment prep, cleaning, sterilization, and environmental monitoring.
• Prepare materials while maintaining identity and following batch monitoring procedures.
• Complete batch records, shipping docs, and training materials accurately and compliantly.
• Support qualification/validation activities and promote GMP compliance and speak-up culture.
• Ensure technicians complete required training and support their development.

Skills

Data Analytics

Education

Bachelor of Science

Tools

MS Office

Job description

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.

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.

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.

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, 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.

Salary Range $85,400.00 - $158,600.00

Skills Desired

Data Analytics

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