RayzeBio
biotechnology
AnalyticalScientistMethodValidation
“Analytical Scientist - Method Validation at RayzeBio. Skills: analytical method development, validation, verification, transfer, ICP-MS, Elemental Impurities testing, GMP compliance. 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 spectr”
What You'll Achieve.
timely delivery of analytical results; support product development and commercialization; ensuring accuracy and reliability of data
Industry & Context.
analytical and problem-solving skills; Participate in troubleshooting and investigations of analytical issues, identify root causes, and implement corrective actions
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, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials
What They're Looking For.
Must Have
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/ 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, Proficient in the use of laboratory instrumentation and Microsoft Office Suite, analytical and problem-solving skills, Ability to multi-task and prioritize work based on multiple workflows, Ability to communicate effectively with multiple stakeholders, written and oral communication skills, Excellent professional ethics, integrity, and ability to maintain confidential information
Nice to Have
Experience with parenteral drugs and/or radiopharmaceutical preferred but not required, Experience with ICP-MS, including verifying USP/ Elemental Impurities and developing and validating ICP-MS methods for dozens of elemental impurities that may be present in raw materials
What You'll Do.
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
and ultra-high-performance chromatography
Prepare analytical test methods and method validation
and transfer protocols and reports in accordance with applicable guidelines and industry standards (e.g. USP
Develop and maintain appropriate documentation
standard operating procedures and associated forms
Participate in troubleshooting and investigations of analytical issues
and implement corrective actions
Participate in instrument qualification
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
and quality standards
Work with RSO to ensure laboratory compliance with the radiation safety programs
Source and on-board analytical technologies as required
How You'll Work.
Team & Collaboration
Collaborate on the development and validation of other methods; 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; Provide technical support to other teams or business units as required; Ability to work independently or in a team environment; Ability to communicate effectively with multiple stakeholders
Communication Scope
Ability to communicate effectively with multiple stakeholders; written and oral communication skills
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