Manager, Production - Indianapolis, IN at Military… · Location…

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

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.