Analytical Scientist – Method Validation Full-time NEW

Analytical Scientist – Method Validation

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

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 radiopharmaceuticals.

RayzeBio, a Bristol Myers Squibb company, is looking for an Analytical Scientist at their Indianapolis manufacturing site. The person will be responsible for method development and implementation, method validation, verifications, or transfer, as well as stability testing activities to support product development at the RayzeBio manufacturing site in Indianapolis. The Analytical Scientist associate will report directly to the Manager of Analytical Development at the Indianapolis site.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Develop and validate analytical methods on an Inductively Coupled Plasma Mass Spectrometry instrument (ICP-MS) for testing Elemental Impurities present in parenteral radiopharmaceutical drugs and raw materials.
• Collaborate on the development and validation of other methods utilizing alpha spectrometers, gamma spectrometers, mass spectrometers, and ultra-high-performance chromatography.
• Prepare analytical test methods and method validation, verification, and transfer protocols and reports in accordance with applicable guidelines and industry standards (e.g. USP, EP, and ICH).
• Develop and maintain appropriate documentation, including notebooks, protocols, reports, standard operating procedures and associated forms, and data analysis.
• Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions.
• Participate in instrument qualification, calibration, and maintenance activities.
• Work closely with other teams to ensure timely delivery of analytical results and support product development and commercialization.
• Participate in method transfer activities from CDMO or internal research facility to QC team, ensuring accuracy and reliability of data.
• Provide technical support to other teams or business units as required.
• Ensure compliance with GMP regulations, safety guidelines, and quality standards.
• Work with RSO to ensure laboratory compliance with the radiation safety programs.
• Source and on-board analytical technologies as required.

• 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

• B.Sc. or M.Sc. in Analytical Chemistry, Pharmaceutical Sciences, or relevant scientific field
• Minimum 5 years of experience in analytical method development, validation, verification, and transfer in the pharmaceutical or radiopharmaceutical industry.
• Prior extensive experience with ICP-MS, including verifying USP<232>/<233> or ICHQ3D(R2) Elemental Impurities and developing and validating custom ICP-MS methods for dozens of elemental impurities that may be present in raw materials.
• Prior experience composing or collaborating on Elemental Impurities risk assessments.
• Prior experience in a GMP pharmaceutical testing laboratory with knowledge of GMP regulations, quality systems, and safety guidelines.

Preferred Experience

• Experience with parenteral drugs and/or radiopharmaceutical preferred but not required.
• Experience with ICP-MS, including verifying USP<232>/<233> Elemental Impurities and developing and validating ICP-MS methods for dozens of elemental impurities that may be present in raw materials

Skills

• Proficient in the use of laboratory instrumentation and Microsoft Office Suite
• Highly motivated and organized professional with the ability to work independently or in a team environment
• Strong analytical and problem-solving skills
• Ability to multi-task and prioritize work based on multiple workflows
• Ability to communicate effectively with multiple stakeholders
• Strong written and oral communication skills
• Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands:

While performing the duties of this job, 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 by this job include close vision and distance vision.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment:

The noise level in the work environment is usually moderate.