Production Lead, Isotopes (3rd shift)

Job description

Location

Indianapolis, IndianaRelocation 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. #LI-Onsite

Responsibilities

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. To learn more about the culture, rewards and benefits we offer our people click here.