Quality Control Environment Monitoring Supervisor

Quality Control Environment Monitoring Supervisor

Company: Bristol Myers Squibb (Rayze Bio, a Bristol Myers Squibb company)

Location: Indianapolis, IN

Challenging. Meaningful. Life-changing. 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 have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.

• Oversee the environmental monitoring (EM) program supporting GMP manufacturing operations related to radiopharmaceuticals.
• Manage EM program including viable, non‑viable, personnel, and 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, and elevate excursions.
• Lead or support investigations for EM‑related issues, including root cause analysis and CAPA development to ensure timely close‑out.
• Maintain EM program documentation such as SOPs, forms, maps that are current and audit‑ready.
• Ensure EM trending, monthly/quarterly reports are performed in a timely manner.
• Approve SOPs, trend data, investigations, non‑conformances, validation protocols, reports, validations/qualifications, and equipment qualifications.
• Develop and maintain appropriate documentation, particularly data analysis and team KPIs.
• Supervise a team of EM technicians/analysts.
• Assign tasks‑and-prioritize workload to ensure timely completion in an on‑time and right‑first‑time manner.
• Foster a positive and collaborative work environment within the lab and with external stakeholders inside 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 and implement process improvements 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 routine calibration and maintenance of laboratory equipment, ensuring schedule compliance to 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 finishing times may be required.
• Up to 10% travel may be required.
• Maintain a regular presence of the EM program during critical manufacturing periods and the release of radiopharmaceutical products.
• Ensure laboratory safety and compliance with radiation safety, hazardous chemicals, and other applicable regulations.

• Education
  : BS in microbiology or related field with 5+ years of direct radiopharmaceutical experience or 5+ years of experience in the pharmaceutical field; or MS in microbiology or related field with 5+ years of experience in the pharmaceutical field.
• At least one year of supervisory experience.
• A strong background in microbiology and aseptic manufacturing is required.
• Preferred experience in the radiopharmaceutical field and handling radioactive materials.
• 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 detail and data integrity.
• Experience with software such as Sherpa or LIMs or…