Sr Associate Scientist - Microbiology

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The position is located at Rayze Bio's manufacturing plant in Indianapolis, IN. It involves testing activities related to radiopharmaceuticals, advanced laboratory analyses, troubleshooting, method validation, and ensuring compliance with regulatory and QA system requirements for radioisotopes and radiopharmaceutical product release. The role supports laboratory compliance with the radiation safety program and requires work with ionizing radiation and hazardous chemicals.

• Laboratory Testing
  • Perform routine microbiological assays including 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 conduct out‑of‑trend analysis.
  • Support investigations/deviations, including root‑cause analysis and CAPA development for timely close‑out.
  • Ensure all assay documentation is audit‑ready.
  • Prioritize workload to ensure timely completion in a right‑first‑time manner.
  • Foster a positive and collaborative work environment within the lab and with external stakeholders.
  • Train team members on assays.
  • Work with Manager and/or Investigation Writer to resolve discrepancies promptly.
• Continuous Improvement
  • Support continuous improvement programs such as new technologies and improve data visibility.
  • Identify and implement opportunities for process improvements to enhance 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 from 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.

• BS in microbiology or related field with 3+ years of direct radiopharmaceutical experience or 4+ years of experience in the pharmaceutical field.
• OR MS in microbiology or related field with 3+ years of experience in the pharmaceutical field.
• A strong background in microbiology and aseptic manufacturing is required.

• Experience in the radiopharmaceutical field.
• Experience handling radioactive materials.

• Highly motivated and organized professional with the ability to work independently or in a team environment.
• Attention to detail and data integrity.
• Experience with software such as Sherpa, LIMs, or an equivalent data system.
• Multidisciplinary 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 across multiple workflows.
• Good organizational skills.
• Proficient with Microsoft Office and multiple computer systems.
• Excellent professional ethics, integrity, and the ability to maintain confidential information.

The employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required include close vision and distance vision. The role requires working in a laboratory environment; protective clothing, gloves, and safety glasses are required while working with radioactive materials.

The noise level in the work environment is usually moderate.

Indianapolis – Rayze Bio – IN: $82,236–$99,650 (full‑time employee). Additional incentive cash and stock opportunities may be available. Final compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Wellbeing Support: BMS Well‑Being Account, BMS Living Life Better, 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.

BMS is committed to providing Equal Employment Opportunity and a safe workplace. A reasonable workplace accommodation / adjustment is available to qualified applicants and employees. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age (40+), disability, military status, or any other protected class.