Associate, Quality Control Data Review

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RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC).  Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

RayzeBio, a Bristol Myers Squibb company, is seeking applicants for a Quality Control Data Reviewer.  We are seeking a detail-oriented Quality Control Data Reviewer to play a key role in the development and commercialization of RayzeBio’s targeted alpha therapy (TAT) radiopharmaceuticals.  Ideally, the candidate will have prior laboratory and technical experience in the radiopharmaceutical industry.  Additional responsibilities may include documenting and/or conducting laboratory investigations.

**This is an onsite position located at Rayzebio's Indianapolis, IN site*

Key Responsibilities:

• Review Quality Control data for accuracy, completeness and compliance with established procedures and regulatory requirements.
• Ensure Quality Control data is reviewed in a timely manner.
• Conduct periodic review and updates of Quality Control Standard Operating Procedures, as necessary.
• Conduct Investigations—Lead and conduct in-depth investigations following standard operating procedures for out of specification results and other quality issues in the quality control laboratory.
• Document Findings of investigations—write detailed investigation reports and work with QA and QC management to propose provide corrective action and corrective training to prevent repeat events.
• Ensure data integrity throughout data review and investigations as required.
• Proactively identify opportunities for improvements to both investigations and the data review processes.
• Position is salaried position, generally first shift, but extended hours or weekend work based on radiopharmaceutical manufacturing schedule may be required
• This position will require the applicant to work with and around ionizing radiation, biohazardous materials, and hazardous chemicals.
• Up to 10% of travel may be required.
• Other duties as assigned by management.

Education & Experience:

• BS in Chemistry, Biology, Science, or relevant field with five to seven years of experience in pharmaceutical or other cGMP experience.  Advanced degrees may be acceptable with less experience, however direct experience with cGMP technical writing is required.
• Thorough understanding of cGMP regulations, ICH guidelines, FDA and other regulatory process investigation process
• Experience with injectable pharmaceuticals or radiopharmaceuticals strongly preferred.
• Experience tracking maintenance of laboratory equipment preferred.

Skills & Qualifications:

• Ability to multi-task, and prioritize work based on multiple work-flows is a must
• Ability to handle hazardous materials safely
• Good organizational practices are required
• Strong analytical and pr