Isotope Manufacturing Lead - Night Shift (cGMP)

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); Vor Ort; USD 57.000 - 105.000; Vollzeit

Benefits dieser Stelle

Health benefits

401(k) with company match

Equity/annual incentive eligibility

Zusammenfassung

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).

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Data Analytics

Ausbildung

Bachelor of Science

Tools

MS Office

Jobbeschreibung

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).