Manager, Production - Indianapolis, IN

VetJobs; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Benefits offered by this job

Discretionary incentive cash

Stock opportunities

Job summary

RayzeBio is seeking a Manager of Production in Indianapolis to lead the radiopharmaceutical drug product manufacturing team, ensuring compliant, on-schedule production for clinical and commercial needs.

You will drive a culture of safety and quality in a GMP environment, manage daily production, and develop a high-performing team focused on reliable supply while collaborating across functions to meet corporate objectives.

Qualifications

• BS or MS in a scientific field or equivalent work experience.
• 5+ years in GMP pharmaceutical manufacturing, radiopharmaceutical or sterile injectable preferred.
• Strong leadership and communication skills.

Responsibilities

• Provide in-plant management of production personnel and ensure GMP compliance.
• Oversee daily production schedules and batch manufacturing of radiopharmaceutical injectables.
• Ensure aseptic technique and sterile manufacturing practices.
• 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

Team leadership

GMP compliance

Communication

AI in ops

Education

BS or MS in scientific field

High School / GED

Job description

Job Description

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

• 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.

Education and Experience

High School / GED

• 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 Demands

While 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.

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.

Salary Range: >$100,000