At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

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. 

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:  

o    Sterility testing 

o    Bioburden testing 

o    Endotoxin testing 

o    Media qualification and growth promotion testing 

o    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 

• 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 1-2 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 environm