Quality Control Environment Monitoring Supervisor

Bristol Myers Squibb•Indianapolis, IN

1d•Onsite

About The Position

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. 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 RayzeBio’s manufacturing plant, in Indianapolis, IN.

Requirements

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.
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.
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.

Nice To Haves

Experience in radiopharmaceutical field
Experience handling radioactive materials
Radiochemistry experience preferred.
Experience with root cause techniques such as 6 M’s, 5 Why’s, fishbone, or similar preferred.

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 KPI’s.
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.
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.
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.
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.

Benefits

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.

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