RayzeBio

Reporting to the Sr. Manager of Quality Control, the Quality Control Chemist will help support the establishment of a new Quality Control laboratory which supports RayzeBio’s Radiopharmaceutical manufacturing facility in Indianapolis.. Upon establishment of the laboratory and program, this position will utilize a wide range of analytical and radiochemical analyses to support the advancement and release of novel targeted radiopharmaceuticals from the R&D phase through clinical development to GMP commercial radiopharmaceutical production.. · Work with RSO to ensure laboratory compliance with the radiation safety programs.. · BS/MS in Chemistry, Science, or relevant field with up to five years of analytical or radiochemistry experience. · Experience with HPLC, TLC, GC, Gamma Spec, and ICP all strongly preferred

quality control chemist

Position: Quality Control Chemist Location: Indianapolis BackgroundRayzeBio 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 DescriptionReporting to the Sr. Manager of Quality Control, the Quality Control Chemist will help support the establishment of a new Quality Control laboratory which supports RayzeBio’s Radiopharmaceutical manufacturing facility in Indianapolis. The Quality Control Chemist will be responsible and/or providing support for the installation, commissioning, qualification, and validation of analytical and radiochemical equipment for the QC lab. Upon establishment of the laboratory and program, this position will utilize a wide range of analytical and radiochemical analyses to support the advancement and release of novel targeted radiopharmaceuticals from the R&D phase through clinical development to GMP commercial radiopharmaceutical production. Specifically, the quality control chemist will support the release of manufactured radiopharmaceuticals to support RayzeBio’s clinical and commercial programs. Job Responsibilities· Provide technical expertise and support for offsite vendors and RayzeBio MS&T and RA/QA teams in the installation and qualification of all laboratory equipment in a GMP environment.· Participate in method transfer activities from CMO or internal research facility to the production and QC teams, ensuring accuracy and reliability of data.· Assist in developing, verifying, and validating analytical methodologies in support of novel RayzeBio radiopharmaceuticals production in a GMP environment.· Write and review 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 analytical issues, identify root causes, and implement corrective actions as required.· Develop and maintain appropriate documentation, including protocol, reports, and data analysis.· 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.· Source and on-board analytical technologies as required.· Position is a salaried, first shift position. Occasional work outside first shift is expected on an as-needed basis. EDUCATION/EXPERIENCE/SKILLSEducation and Experience:· BS/MS in Chemistry, Science, or relevant field with up to five years of analytical or radiochemistry experience· Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred· Experience with HPLC, TLC, GC, Gamma Spec, and ICP all strongly preferred Skills:· Highly motivated and organized professional with the ability to work independently or in a team environment· Multi-disciplined scientist with GMP experience· Experience with root cause techniques such as 6 M’s, 5 Why’s, fishbone, or similar preferred· Very personable with strong communication skills· Excellent professional ethics, integrity, and ability to maintain confidential information· Must be comfortable working in a controlled environment with ionizing radiation and able to lift 40 lbs. Compensation: Competitive base salary with bonus, stock options, and full benefits Benefits<ul><li>Medical, Dental and Vision plans</li><li>Life, Accidental Death, Personal Loss, and Disability</li><li>Flexible Spending Account (FSA)</li><li>401(k) Retirement Plan</li><li>Paid Time Off</li><li>Company paid holidays</li></ul> *Multiple positions available at multiple levels.

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