Sr Associate Scientist I - Microbiology

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RayzeBio is seeking a Sr Associate Scientist 1- Microbiology, reporting to the Director- Microbiology Quality Control.  The position will support testing activities related to radiopharmaceuticals. This role will also involve advanced laboratory analyses, troubleshooting efforts, method validation and qualifications ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release.  The Sr Associate Scientist 1 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

• Laboratory Testing
  • Perform routine microbiological assays including but not limited to bioburden, endotoxin, sterility, environmental monitoring, microbial identification and media qualification testing.
  • Execute method qualification, verification and validation studies with minimal supervision.
  • Troubleshoot assay related issues and perform out of trend analysis.
  • Support investigations/deviations, including root cause analysis and CAPA development to ensure timely close-out.
  • Ensure all assay documentation is audit ready.
  • Prioritize workload to ensure timely completion of 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.
  • Train team members on assays.
  • Work with Manager and/or Investigation Writer to ensure any discrepancies are resolved in a timely manner.
• Continuous Improvement
  • Support continuous improvement programs such as new technologies and improve data visibility.
  • Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories.
• Quality Assurance/Regulatory Compliance
  • 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.

Education and Experience

·BS in microbiology or related field with 3+ years of direct radiopharmaceutical experience or 4+ years of experience in pharmaceutical field, OR MS in microbiology or related field with 3+ years of experience in pharmaceutical field.

·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.
• 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 M’s, 5 Why’s, 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 organ