GMP Radiopharma Production Manager

Bristol Myers Squibb EU Policy; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Job summary

RayzeBio in Indianapolis seeks a Manager of Production to oversee day-to-day GMP radiopharmaceutical injectables manufacturing, ensuring quality, safety, and on-time delivery. You’ll lead a cross-functional team and drive continuous improvement in a highly regulated setting.

The role requires a BS/MS in a scientific field and at least 5 years of GMP pharma manufacturing experience, with emphasis on sterile injectable products and radiopharmaceuticals.

Qualifications

• BS or MS in scientific field (or equivalent).
• At least 5 years of GMP pharmaceutical manufacturing experience; radiopharmaceutical or sterile injectable preferred.

Responsibilities

• Provide in-plant management of production personnel and ensure GMP compliance for clinical and commercial drug product manufacturing.
• Oversee daily production schedules and batch manufacturing of radiopharmaceutical injectables to meet supply demands.
• Ensure aseptic technique and sterile manufacturing practices are followed for the production of injectable drug product to maintain product quality and patient safety.
• Manage the cleaning and sanitization of the production clean suite.
• Support the development and implementation of a robust operator qualification program.
• Draft GMP documentation including but not limited to Batch Records, SOP's, Forms, Deviations, CAPA's, Change Controls and reports.
• Support investigations and implement corrective and preventative action plans.
• Monitor and manage production department KPI's related to performance and throughput of GMP radiopharmaceutical operations.
• Ensure compliance with NRC, EH&S and US/EU GMP regulatory guidelines as required.

Skills

GMP knowledge

Team leadership

Communication skills

Integrity and ethics

AI for decision-making

Education

BS or MS in scientific field

Job description

RayzeBio in Indianapolis seeks a Manager of Production to oversee day-to-day GMP radiopharmaceutical injectables manufacturing, ensuring quality, safety, and on-time delivery. You’ll lead a cross-functional team and drive continuous improvement in a highly regulated setting.

The role requires a BS/MS in a scientific field and at least 5 years of GMP pharma manufacturing experience, with emphasis on sterile injectable products and radiopharmaceuticals.