Quality Control Environment Monitoring Supervisor

Role Summary

Quality Control Environment Monitoring Supervisor at RayzeBio (a Bristol Myers Squibb company) located in Indianapolis, IN. You will oversee the environmental monitoring program supporting GMP manufacturing operations related to radiopharmaceuticals, manage day-to-day EM activities (viable/non-viable monitoring), ensure data trending and regulatory compliance, and collaborate with the Radiation Safety Officer to maintain laboratory safety and quality standards.

Responsibilities

• Manage EM program
• Supervise EM technicians/analysts performing viable, non-viable, personnel, and settling plates monitoring in ISO-classified spaces
• Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness
• Oversee 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 EM-related investigations, including root cause analysis and CAPA development
• Ensure EM program documentation (SOPs, forms, maps) is 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, and equipment qualifications
• Develop and maintain 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
• Foster a positive and collaborative work environment within the lab and with stakeholders
• Coach team members, conduct performance evaluations and support career development
• Continuous Improvement
• Support continuous improvement programs for EM and adopt new EM technologies to improve data visibility
• Identify opportunities for process improvements and implement changes to increase quality and efficiency
• Release of isotope, product and other studies
• Collaborate to ensure documentation for release is reviewed; resolve discrepancies in a timely manner
• Quality Assurance/Regulatory Compliance
• Assist in routine calibration and maintenance of laboratory equipment; ensure GMP readiness
• Work with QA and Management to implement internal audits
• Participate in troubleshooting and implement corrective actions from investigations or audits
• Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, etc.)
• Weekend work, early starts, or late ending times may be required
• Up to 10% travel may be required

Qualifications

• BS in microbiology or related field with 5+ years of direct radiopharmaceutical or pharmaceutical field experience, OR MS in microbiology or related field with 5+ years of experience in pharmaceutical field
• At least one year of supervisory experience
• Strong background in microbiology and aseptic manufacturing
• Preferred: experience in radiopharmaceutical field
• Preferred: experience handling radioactive materials

Skills

• Highly motivated and organized professional with the ability to work independently or in a team
• Proficient in viable and non-viable monitoring techniques
• Strong understanding of cleanroom classifications
• Attention to data integrity and detail
• Experience with software such as Sherpa or LIMS or equivalent data systems
• GMP experience; radiochemistry experience preferred
• Experience with root cause techniques (6 M's, 5 Why's, fishbone, etc.) preferred
• Strong communication and cross-functional collaboration
• Ability to multi-task and prioritize across multiple workflows
• Good organizational skills
• Proficiency with Microsoft Office and multiple computer systems
• Professional ethics and ability to maintain confidential information

Education

• BS in microbiology or related field required; MS in microbiology or related field preferred

Additional Requirements

• Work may require working in a laboratory environment with protective clothing, gloves, and safety glasses when handling radioactive materials
• Physical demands include ability to move up to 40 pounds and maintain visual/endurance requirements
• Travel up to 10% may be required