Manager, Production - Indianapolis, IN
About The Position
The Manager of Production will be responsible for the day-to-day oversight, execution, and leadership of the drug product manufacturing team engaged in the production of radiopharmaceutical injectables at clinical and commercial scale. The Manager of Production will drive a culture of compliance, safety, and teamwork in a GMP radiopharmaceutical environment while ensuring drug products are manufactured on schedule and in accordance with all applicable quality and regulatory standards. The Manager of Production will work cross functionally to meet corporate objectives and support systems related to the commercialization of RayzeBio’s programs. The Manager of Production will lead and develop a team of high performers to ensure a consistent, reliable, and timely supply of clinical and commercial drug products.
Requirements
- BS or MS in scientific related field or equivalent work experience
- At least 5 years of experience in a GMP pharmaceutical manufacturing environment, with radiopharmaceutical or sterile injectable manufacturing experience preferred.
- Highly motivated and organized professional with strong interpersonal and communication skills.
- Proven experience building and managing teams in a GMP environment.
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Applies AI to improve team execution and decision‑making
Nice To Haves
- radiopharmaceutical or sterile injectable manufacturing experience 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.
Benefits
- additional discretionary incentive cash and stock opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Manager
