RayzeBio:

https://careers.bms.com/rayzebio/

Summary
The Deviation Investigator leads compliant manufacturing deviation investigations in a GMP radiopharmaceutical environment. The role partners with cross-functional teams to assess product quality impact, determine root cause, define CAPAs, and support timely product release and quality commitments.
Key Responsibilities
+ Lead, document, and close manufacturing deviation investigations in alignment with GMP requirements and internal procedures.

+ Apply root cause analysis tools and risk-based decision-making to assess scope, recurrence, and product quality impact. + Review batch records, equipment records, electronic data, logbooks, environmental monitoring, analytical data, and other supporting documentation. + Partner with Manufacturing, Quality, Engineering, Validation, MS&T, and other SMEs to gather evidence and develop scientifically justified conclusions. + Develop and manage CAPAs, including effectiveness criteria, due dates, and timely closure. + Draft and revise GMP documentation, including deviations, CAPAs, SOPs, forms, change controls, reports, and supporting records. + Monitor trends, KPIs, and recurring issues to support continuous improvement, inspection readiness, and quality system performance. + Support internal audits, health authority inspections, product release timelines, and other site business needs as assigned.

Education and Experience
+ Bachelor's or master's degree in a scientific, engineering, pharmaceutical, biotechnology, or related field; equivalent experience may be considered.

+ 2-7 years of experience in GMP manufacturing, quality, validation, MS&T, technical operations, or a related regulated environment. + Experience in radiopharmaceutical, sterile injectable, aseptic, biologic, pharmaceutical, or similar regulated manufacturing preferred. + Experience with deviation investigations, root cause analysis, CAPA development, GMP documentation, and inspection readiness preferred.

Required Skills and Qualifications
+ Strong technical writing skills and ability to produce clear, audit-ready GMP documentation.

+ Working knowledge of cGMP, quality systems, deviation management, CAPA, change control, and data integrity expectations. + Strong analytical, organizational, interpersonal, facilitation, and communication skills. + Ability to manage multiple priorities and drive investigations to closure in a fast-paced environment. + High degree of ownership, independence, accountability, sound judgment, ethics, and confidentiality. + Proficiency with electronic quality systems, document management systems, Microsoft Office, and data review tools preferred.

Physical Demands and Work Environment
The employee is regularly required to sit, stand, walk, reach, and communicate.

The role may require occasional lifting or moving up to 30 pounds and use of close and distance vision. This position may require work in or support of a GMP cleanroom environment, including gowning, protective clothing, controlled-area procedures, and radioactive material handling. The noise level is generally moderate. \\#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:
$34.05
$41.

26per 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.

R1604843

: Deviation Investigator

Req Number:
R1604843
Location:
Indianapolis
Indiana
USBristol Myers Squibb is an equal opportunity employer.

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