Production Lead, Isotopes (3rd shift)
About The Position
The Production Lead, Isotopes is a hands-on manufacturing role supporting the production and delivery of Radioligand Therapy isotope products. The role helps guide and develop production technicians, maintain production readiness, and ensure work is completed safely, on time, and in accordance with current Good Manufacturing Practice (cGMP) 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. This is an onsite, third-shift position in Indianapolis, Indiana. Expected hours are 10 p.m. to 6 a.m., Monday through Friday; schedules may change based on business needs. Novartis does not offer relocation support for this role.
Requirements
- A Bachelor of Science is strongly preferred; a minimum of 2 years of experience in a cGMP or aseptic environment may substitute for a degree.
- 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 for extended periods.
Nice To Haves
- Low bioburden manufacturing experience.
- Experience or training in radiochemistry or radiopharmacy.
- Data analytics.
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 cGMP compliance and a speak-up culture.
- Ensure technicians complete required training and support their professional development.
Benefits
- Performance-based cash incentive.
- Depending on role level, eligibility to be considered for annual equity awards.
- Health benefits.
- Life benefits.
- Disability benefits.
- 401(k) with company contribution and match.
- Vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
