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 while helping 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 Production Lead works with production leadership and cross-functional partners to promote operational excellence, a strong quality culture, and continuous improvement across the manufacturing environment. This is an onsite, third-shift role in Indianapolis, Indiana. Expected hours are 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 expected hourly salary range is $41.05 to $76.25. Final compensation depends on factors including relevant skills and experience, and may be reviewed periodically. Compensation includes a performance-based cash incentive and, depending on role level, possible consideration for annual equity awards. Eligible U.S.-based employees receive health, life, and disability benefits; a 401(k) with company contribution and match; other benefits; and time off including 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 in accordance with production, quality, and radiation safety requirements.
Operate and maintain Grade C isolators according to 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.
Accurately and compliantly complete batch records, shipping documents, training materials, and other required production documentation.
Support qualification and validation activities while promoting cGMP compliance and a speak-up culture.
Ensure technicians complete required training and support their professional development.