Quality Control Environment Monitoring Supervisor

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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.

• RayzeBio is seeking a Quality Control Environment Monitoring Supervisor reporting to the Director- Microbiology Quality Control. The position will provide oversight for the environmental monitoring program supporting the GMP manufacturing operations related to radiopharmaceuticals. This role will be responsible for the day-to-day EM activities including viable/non-viable monitoring. The supervisor will ensure data trending are executed in compliance with regulations and company quality standards troubleshooting efforts ensuring compliance with regulatory and QA system requirements and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release. The Environment Monitoring Supervisor 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 RayzeBios manufacturing plant in Indianapolis IN.
• Job Responsibilities
• Manage EM program
  • Supervise EM technicians /analysts performing viable non-viable personnel settling plates monitoring in ISO- classified and controlled spaces.
  • Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness.
  • Oversee execution of environmental and utility sampling including microbial identification workflows.
  • Ensure laboratory activities follow SOPs aseptic techniques gowning procedures and safety requirements.
  • Review and/or approve EM data escalate excursions.
  • Lead or support investigations for EM -related investigations including root cause analysis and CAPA development to ensure timely close-out.
  • Ensure EM program documentation such as SOPs forms maps are current and audit-ready.
  • Ensure EM trending monthly/quarterly reports are performed in a timely manner.
  • Approval of SOPs trend data investigations non-conformances validation protocols reports validation/verifications and equipment qualifications.
  • Develop and maintain appropriate documentation particularly data analysis and team KPIs.
• Team Management
  • Supervise a team of EM technicians /analysts.
  • Assign tasks and prioritize workload to ensure timely completion of in an on-time and right first time manner.
  • Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the site.
  • Coach team members conduct performance evaluations and support career development.
• Continuous Improvement
  • Support continuous improvement programs for EM such as new EM technologies and improve data visibility.
  • Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories.
• Release of isotope product and other studies
  • Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed.
  • Work with Manager and/or Investigation Writer to ensure any discrepancies are resolved in a timely manner.
• Quality Assurance/Regulatory Compliance
  • Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness.
  • Work with Quality Assurance and Management to implement internal audits.
  • Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits.
• Work with RSO and QA to ensure compliance with GMP regulations safety guidelines and quality standards (FDA USP NRC EP and other regulatory agencies as needed).
• Weekend work early starts or late ending times may be required.
• Up to 10% of travel may be required.

• Education and Experience
• BS in microbiology or related field with 5 years of direct radiopharmaceutical experience or 5 years of experience in pharmaceutical field OR MS in microbiology or related field with 5 years of experience in pharmaceutical field.
• At least a year of supervisory experience.
• A strong background in microbiology and aseptic manufacturing is required.
• Preferred Experience:
• Experience in radiopharmaceutical field
• Experience handling radioactive materials

• Skills:
• Highly motivated and organized professional with the ability to work independently or in a team environment.
• Proficient in viable and non-viable monitoring techniques
• Strong understanding of cleanroom classifications
• Attention to details and data integrity
• Experience with software such as Sherpa or LIMs or equivalent data systems
• Multi-disciplined scientist with GMP experience. Radiochemistry experience preferred.
• Experience with root cause techniques such as 6 Ms 5 Whys fishbone or similar preferred.
• Very personable with strong communication skills and cross-functional collaboration
• Ability to multi-task and prioritize work based on multiple workflows.
• Good organizational skills are required.
• Work with multiple computer systems including Microsoft Office.
• Excellent professional ethics integrity and ability to maintain confidential information

• Physical Demands
• While performing the duties of thisjob 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 thisjobincludeclose 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.
• WorkEnvironment
• The noise level in theworkenvironment is usually moderate.
• #LI-ONSITE

If you come across a role that intrigues you but doesnt 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.

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 employees 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 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: The 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.

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.

Supporting People with Disabilities

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 . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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