SummaryThe 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 ResponsibilitiesEssential 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.
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 EnvironmentThe noise level in the work environment is usually moderate.
#LI-Onsite
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.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
