Senior Scientist, Method Development (Regulated Bioanalysis)
About The Position
The Senior Scientist, Method Development will evaluate and implement bioanalytical methods during development and provide leadership in bioanalytical and biomarker method development, validation, and study support for development compounds across modalities, primarily using LC-MS technology. The position also serves as a technical expert in evaluating advanced laboratory equipment. There are opportunities to act as a bioanalytical or biomarker lead on cross-functional study teams and help address related issues. The role conducts in-house bioanalytical and biomarker support for development programs in a regulated laboratory, from tandem mass spectrometry-based method development and validation through sample analysis, data interpretation, and report preparation. It includes technical work on sample cleanup, chromatography, mass spectrometric instrumentation, and method-related issues, as well as collaboration with bioanalytical CROs and knowledge transfer of novel technologies. The scientist communicates project status and scientific trends through written and oral summaries and presentations.
Requirements
- Ph.D. or equivalent advanced degree in the Life Sciences.
- At least 2 years of academic and/or industry experience; the posting also separately lists 4+ years of academic and/or industry experience.
- Good understanding of bioanalysis and biomarkers and their roles in drug development, including method development, validation, study support, and the impact of quality data on PK/PD correlation.
- Strong LC-MS/MS skills for separation and quantitation or identification of small or large molecule therapeutics and biomarkers in biological matrices.
- Experience performing LC-MS/MS and LBA method development, qualification or validation, and study sample analysis in a regulated environment supporting preclinical and clinical studies.
- Proven track record of method development accomplishments, demonstrated through presentations or publications.
- Good communication skills and experience authoring and reviewing bioanalytical and biomarker assays, troubleshooting assay issues, and directing junior scientists.
- Ability to multitask and work collaboratively in a team environment.
Nice To Haves
- Degree in chemistry, biochemistry, biology, or a related field.
- Relevant drug development experience at a pharmaceutical company or bioanalytical and biomarker CRO.
- Strong foundation and experience using, maintaining, and troubleshooting mass spectrometers.
Responsibilities
- Evaluate and apply novel techniques or approaches to address challenging bioanalytical and biomarker issues.
- Provide in-house bioanalytical and biomarker support for development programs, including tandem mass spectrometry-based method development, validation, sample analysis, data interpretation, and report preparation in a regulated laboratory.
- Serve as a technical expert on sample cleanup, chromatography, mass spectrometric instrumentation, stability, and other method-related issues.
- Interact with bioanalytical CROs to address method-related issues and lead knowledge transfer of novel technologies.
- Keep management informed of project status and current scientific trends through written and oral summaries and presentations.
- Author and review bioanalytical and biomarker assays, troubleshoot assay issues, and direct junior scientists.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
- Paid company holidays.
- Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
- Potential eligibility for additional discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
