Manager, Production - Indianapolis, IN

United States·Indianapolismid

OtherProduction

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Quick Summary

Overview

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,

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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.

Responsibilities

~2 min read

Education and Experience

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.
Skills and Qualification

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
Physical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Indianapolis - RayzeBio - IN: $124,449 - $150,803

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.