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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 environments, with PPE required in certain areas.

Work Environment

Moderate noise levels.

Exposure to manufacturing, laboratory, and logistics environments.

#LI-Onsite

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Indianapolis - RayzeBio - IN: $31.07 - $37.64per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

**** Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.

R1605094 : Data Reviewer, Quality Control Microbiology

Req Number: R1605094

Location: Indianapolis - Indiana - US

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.