Microbiology Manager Jobs in Indiana (NOW HIRING)

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Job Description:
RayzeBio is seeking a Quality Control Microbiology Laboratory Supervisor, reporting to the Director- Microbiology Quality Control. The position will provide oversight for the daily microbiology activities supporting the GMP manufacturing operations related to radiopharmaceuticals. 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 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.
Job Responsibilities:
Supervise daily QC Microbiology activities including, but not limited to:
Sterility testing
Bioburden testing
Endotoxin testing
Media qualification and growth promotion testing
Environmental Monitoring (viable air, surface, and personnel)
Perform microbiology laboratory assays when needed.
• Maintain strict adherence to aseptic technique, gowning practices, and cleanroom behaviors during laboratory activities.
Ensure all laboratory testing is performed in accordance with approved SOPs, validated methods, and regulatory requirements.
Review, approve, and/or verify microbiological data, logbooks, and electronic records to ensure accuracy, completeness, and ALCOA+ data integrity principles.
Ensure laboratory equipment, materials, and reagents are within calibration, qualification, and expiry prior to use.
Maintain inspection-ready documentation and support internal audits, regulatory inspections, and third-party assessments.
Supervise, coach, and mentor QC Microbiology analysts and/or technicians.
Assign and prioritize workload to ensure testing is completed "on-time and right-first-time."
Conduct performance feedback, support skill development, and assist with onboarding and qualification of new hires.
Ensure personnel are properly trained and qualified on methods, SOPs, aseptic techniques, gowning, and safety requirements, including participation in Train-the-Trainer activities where applicable.
Partner with Manufacturing, QA, Facilities, Engineering, MS&T, and Radiation Safety to support production, facility readiness, and product release.
Identify opportunities for process improvement, automation, and efficiency within the QC Microbiology laboratory.
Support method lifecycle activities, equipment qualification, and technology improvements as needed.
Additional Qualifications/Responsibilities
Education and Experience
Bachelor's degree (BS) in Microbiology, Biology, or a related life science discipline required.
Advanced degree (MS) preferred.
Minimum 5+ years of experience in a QC Microbiology or related laboratory within a cGMP-regulated environment.
Prior supervisory experience strongly preferred.
Experience supporting sterile manufacturing and/or radiopharmaceutical operations is highly desirable.
Strong working knowledge of microbiological methods, EM programs, and regulatory expectations.
Skills & Competencies
Demonstrated leadership and personnel management skills.
Strong knowledge of cGMP, USP <61>, <62>, <71>, <85>, EU GMP Annex 1, and data integrity principles.
Ability to investigate microbiological excursions and deviations using risk-based approaches.
Excellent written and verbal communication skills.
Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
Ability to work in classified cleanroom environments while wearing appropriate gowning.
Flexible schedule, including occasional weekend or off-shift support based on business needs.
Uses AI tools to enhance individual productivity and quality of work
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.
Compensation Overview:
Indianapolis - RayzeBio - IN: $107,904 - $130,754
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 employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.