Location: Indianapolis, IN
Background:
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Job Description:
Reporting to the Asst. Manager of Microbiology, the Microbiologist will help support the establishment of a new Environmental Monitoring/Microbiology laboratory which supports RayzeBio’s Radiopharmaceutical manufacturing facility in Indianapolis. The Microbiologist will be providing support for the commissioning, qualification, and validation of cleanroom environments and equipment and the associated environmental monitoring program. Upon establishment of the laboratory and program, the position will support the environmental monitoring and microbiological release testing of manufactured radiopharmaceuticals to support RayzeBio’s clinical and commercial programs.
Job Responsibilities:
- Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data.
- Perform environmental monitoring using lab equipment and techniques (viable airborne monitoring (active and passive), total airborne particulate sampling, viable surface monitoring, personnel monitoring)
- Perform microbiological analyses of validated/verified methods to support novel Radiopharmaceuticals, raw materials, and components.
- Perform Growth Promotion testing per USP Methods for various microbiological media.
- Analyze Biological Indicators in support of Validation and Qualification activities.
- Read plates to quantify microbial growth and subculture pure isolates as required.
- Ensure the use of proper aseptic technique during monitoring of controlled environments.
- Assist in the reviewing of laboratory Standard Operating Procedures (SOP’s) and related documents.
- Assist in the routine calibration and maintenance of all laboratory equipment and materials.
- Participate in troubleshooting and investigations of environmental excursions, identify root causes, and implement corrective actions as required.
- Prepare sample data, results, reports and other documents that are generated in microbiology and environmental monitoring lab.
- Participate and support instrument qualification, calibration, and maintenance activities.
- Ensure compliance with GMP regulations, safety guidelines, and quality standards.
- Work with RSO to ensure laboratory compliance with the radiation safety programs.
- Provide technical support to other teams or business units as required.
- Perform other general duties associated with the position as required by supervision.
EDUCATION/EXPERIENCE/SKILLS
Education and Experience:
- BS/MS in Biology, Microbiology, or other Life Science related field with up to five years of relevant experience in production or quality control in a cGMP/FDA regulated facility.
- Experience with sterile manufacturing and/or radiopharmaceuticals strongly preferred.
Skills:
- Highly motivated and organized professional with the ability to work independently or in a team environment.
- Strong written and verbal communication skills required.
- Excellent professional ethics, integrity, and ability to maintain confidential information.
- Must be comfortable gowning in PPE to work in a cleanroom environment, working with ionizing radiation, and able to lift 40 lbs.
COMPENSATION: Competitive base salary with bonus, stock options, and full benefits
Benefits
- Medical, Dental and Vision plans
- Life, Accidental Death, Personal Loss, and Disability
- Flexible Spending Account (FSA)
- 401(k) Retirement Plan
- Equity/stock options
- Paid Time Off
- Company paid holidays
Please apply through our RayzeBio LinkedIn