Production Lead, Isotopes (3rd shift)

Novartis•Indianapolis, IN

8d•Onsite

About The Position

The Production Lead, Isotopes, performs hands-on daily manufacturing of Radioligand Therapy isotope products and helps guide and develop production technicians. The role supports production readiness and ensures work is completed safely, on time, and in accordance with current Good Manufacturing Practice (cGMP), quality, and radiation safety requirements. The position works with production leadership and cross-functional partners to promote operational excellence, a strong quality culture, and continuous improvement. This is an onsite third-shift role in Indianapolis, Indiana, with expected hours of 10 p.m. to 6 a.m., Monday through Friday. Shift schedules may change based on business needs. Novartis does not offer relocation support for this role. The position involves operating Grade C isolators, preparing equipment and materials, completing production documentation, supporting qualification and validation activities, and ensuring technicians complete required training. The salary is expected to range from $41.05 to $76.25 per hour; the final offer depends on factors including relevant skills and experience. Compensation includes a performance-based cash incentive and, depending on role level, possible eligibility for annual equity awards. Eligible US-based employees receive health, life, and disability benefits, a 401(k) with company contribution and match, and paid time off that includes vacation, personal days, holidays, and other leaves.

Requirements

A Bachelor of Science is strongly preferred; applicants without a degree may substitute at least 2 years of experience in a cGMP or aseptic environment.
At least 4 years of experience in pharmaceutical manufacturing.
Strong understanding of manufacturing and validation requirements and activities.
Knowledge of cGMP regulations and FDA guidance applicable to isotope manufacturing.
Proficiency 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 to perform manufacturing activities while wearing respiratory protection equipment for extended periods.

Nice To Haves

Experience in low bioburden manufacturing.
Experience or training in radiochemistry or radiopharmacy.

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.