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Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Position Summary

RayzeBio, a Bristol Myers Squibb company, is looking for a Director, Microbiology and Environmental Monitoring at their Indianapolis manufacturing site. The person will be responsible for operating the microbiology and sterility testing laboratory, managing a team of microbiologists, supervising the day-to-day activities to support clean room environmental monitoring, GMP testing and release of radiopharmaceutical drug substances/products. The Director, Microbiology and Environmental Monitoring will report directly to the Senior Director, Analytical Chemistry at the Indianapolis site.

Job Responsibilities:

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

+ Develop and implement strategic plans to guide microbiological and Environmental Monitoring (EM) activities from Investigational New Drug (IND) stages through commercialization. Ensure alignment with regulatory requirements and product development timelines.

+ Establish and oversee policies and procedures for microbiology laboratory operations, ensuring compliance with regulatory standards, optimizing laboratory efficiency, and maintaining high-quality assurance and in sample processing, testing, and reporting.

+ Lead and direct a team of Microbiology lab analysts and EM personnel, supervising daily operations and managing its various components to support clinical and commercial production, while ensuring critical deliverables and timelines are met.

+ Drive microbial test method development, technology transfer, method qualification and validation for bioburden, sterility, and endotoxin testing.

+ Oversee microbiological testing procedures, including water sampling, bioburden, sterility and endotoxin testing, growth promotion, microorganism identification, contamination control, etc.

+ Supervise environmental monitoring activities, including routine and non-routine sampling (i.e., Media Fill, EMPQ), sample incubation, result reporting, and microbial identification based on production needs.

+ Analyze and trend environmental and personnel monitoring data, conduct risk assessments, and develop and implement contamination control strategies to maintain product integrity.

+ Lead investigations related to Out of Specification (OOS) or Out of Trend (OOT) results, environmental monitoring excursions, and contamination events. Oversee deviations, implement corrective and preventive actions (CAPA), and ensure timely resolution.

+ Act as a subject matter expert (SME) on microbiological testing and EM in multidisciplinary project teams.

+ Support regulatory compliance efforts, participating in internal audits and inspections by external agencies and Regulatory Authorities to confirm compliance and identify areas for improvement.

+ Collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site.

+ Develop KPI's to ensure operational excellence and compliance with GMP's.

+ Manage laboratory operations budget and forecast.

+ Perform other duties as required by management.

+ The position is salaried. Work will be predominantly first shift, M-F, but extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required.

+ This position will require the applicant to work with and around ionizing radiation and hazardous chemicals.

Education and Experience

+ BS, MS, or PhD in Microbiology, Biology, or a relevant scientific field.

+ A minimum of 10 years of experience in GMP microbiological testing or environmental monitoring to support aseptic manufacturing and production

+ Proven leadership and management experience in a GMP regulated environment. At least 5 years in a leadership or management role, overseeing microbiology and EM teams.

+ Experience with environmental monitoring program, including viable/non-viable air sampling, water and gas testing, and cleanroom qualification.

+ Strong knowledge of microbiological techniques, sterility assurance, and contamination control.

+ Thorough understanding of cGMP regulations, ICH guidelines, quality system, and safety guidelines.

+ Experience in sterile pharmaceutical manufacturing is required and experience in radiopharmaceuticals is preferred but not required.

Skills:

+ Strong leadership, communication, and team management skills

+ Ability to drive continuous improvement and operational efficiency

+ Excellent problem-solving skills and ability to lead investigations

+ Ability to multi-task and prioritize work based on multiple workflows

+ Ability to communicate effectively with multiple stakeholders

+ Proficient in the use of laboratory instrumentation and Microsoft Office Suite

+ Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands:

While 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 40 pounds. Specific vision abilities required by this job include close vision and distance vision.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials .

Work** **Environment:

The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $ 190,989 - $231,400 , plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

\#RayzeBio, GPS_2025, #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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is 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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS 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/

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

**Company:** Bristol-Myers Squibb

**Req Number:** R1592657

**Updated:** 2025-06-10 02:29:36.600 UTC

**Location:** Indianapolis-IN

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.