Data Reviewer, Quality Control Microbiology

Summary

RayzeBio is seeking a Quality Control Microbiology Data Reviewer, reporting to the Director- Microbiology Quality Control. The Data Reviewer will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

The position will be located at RayzeBio's manufacturing plant, in Indianapolis, IN.

Regarding work hours, we ask for candidates to be able to work a flexible schedule, including occasional weekend or off-shift support based on business needs. This position is an on-site position.

Job Responsibilities

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

• Review and approve raw microbiological data including, but not limited to:
• Sterility testing
• Bioburden testing
• Endotoxin testing
• Media qualification and growth promotion testing
• Environmental Monitoring (viable air, surface, and personnel)
• Verify that out-of-specification (OOS), out-of-trend (OOT), and atypical results are properly identified, documented, and investigated
• Support microbiological investigations at the site.
• Ensure data is reviewed within defined timelines to support batch release and regulatory reporting
• Ensure all reviewed data meets cGMP, FDA, EMA, USP, and ICH requirements
• Support internal and external audits and inspections; serve as a subject matter expert for data review processes
• Author, review, and approve SOPs, batch records, protocols, and technical reports related to microbiological testing
• Compile and trend EM and microbiological data for periodic review reports and management review
• Identify data integrity issues and escalate appropriately in accordance with site procedures
• Partner with Production, Quality Assurance, Validation, and Regulatory Affairs teams to resolve data discrepancies and support investigations (e.g., CAPAs, deviation reports)
• Support method validation and qualification activities by reviewing generated data packages
• Identify non-value-add review steps and propose process improvements to streamline workflows and reduce cycle times

Education and Experience

• Bachelor's degree (BS) in Microbiology, Biology, or a related life science discipline required.
• Minimum 3-5 years of experience in a QC Microbiology or related laboratory within a cGMP-regulated environment.
• Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.
• Strong working knowledge of microbiological methods, EM programs, and regulatory expectations.

Skills and Qualifications

• Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
• Strong knowledge of cGMP, USP <61>, <62>, <71>, <85>, EU GMP Annex 1, and data integrity principles.
• Ability to manage multiple review tasks under tight deadlines
• Effective communication skills - able to clearly document findings and interface with cross-functional teams
• Proactive in identifying process gaps and challenging the status quo to drive improvements
• Excellent written and verbal communication skills.
• Ability to work in classified cleanroom environments while wearing appropriate gowning.
• Uses AI tools to enhance individual productivity and quality of work

Physical Demands

• Regular interaction within office, warehouse, and manufacturing environments, with PPE required in certain areas.
• Work Environment
• Moderate noise levels.
• Exposure to manufacturing, laboratory, and logistics environments.
• #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: $82,236 - $99,650

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.

RayzeBio and Bristol Myers Squibb

RayzeBio 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.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at with the Job Title and Requisition number.
• Do not send application-related inquiries to this email.
• To check your application status, please login to your Candidate Home Account.

R1607426: Data Reviewer, Quality Control Microbiology