Manager, Analytical Development

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RayzeBio, a Bristol Myers Squibb company, 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 radiopharmaceutical.

RayzeBio, a Bristol Myers Squibb company, is looking for a Manager, Analytical Development at their Indianapolis manufacturing site. The person will be responsible for method development/implementation, method validation/transfer, special studies to support product development as well as stability testing activities if needed. The Manager, Analytical Development will report directly to the director of analytical chemistry at the Indianapolis site.  

Job Responsibilities:
Essential duties and responsibilities include the following.  Other duties may be assigned.
•    Develop a comprehensive roadmap and strategic plan to guide analytical development activities from Investigational New Drug (IND) stages through to commercialization. This includes designing and implementing phase-appropriate analytical methods, ensuring compliance with regulatory requirements, and aligning with product development timelines. 
•    Collaborate cross-functionally to support method development, validation, transfer, and lifecycle management to ensure robust and scalable analytical processes for successful product launch and commercial supply.
•    Mentor and lead a team of scientists in the development, evaluation and implementation of analytical procedures relevant to product characterization and qualification testing.
•    Oversee and participate in developing, optimizing and validating analytical methods for raw materials and injectable radiopharmaceutical products according to phase appropriate and compendial guidelines, including HPLC, GC, TLC, ICP, and other techniques as required.
•    Participate in method transfer activities from CMO or internal research facility to QC team, ensuring accuracy and reliability of data.
•    Design and lead special studies such as forced degradation, in-use stability, compatibility studies etc. as needed, to support new drug filings and regulatory submissions.
•    Prepare and review appropriate documentation, including Standard Operating Procedures, analytical test methods and method validation/transfer protocols and reports, data analysis, risk assessment, and related procedures in accordance with applicable guidelines (e.g. USP, EP, and ICH).
•    Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
•    Participate as needed in instrument qualification, calibration, and maintenance activities.
•    Work with RSO to ensure compliance with established radiation safety programs.
•    Perform other duties as required by management.
•    The position is salaried.  Work will be predominantly first shift, M-F, 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 and hazardous chemicals.

Education and Experience

·      BS degree with 10 years of experience, Master’s degree with 8 years or PhD with 6 years of  industrial experience of industrial experience in analytical method development, validation, and transfer within the pharmaceutical industry to support product development.