Scientist/Senior Scientist – Bioanalytical

Location
San Francisco, CA
Posted
May 03, 2022
Ref
6112116002
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.


Position

Nurix is seeking an enthusiastic and highly motivated individual to support research and preclinical development bioanalytical activities. The successful candidate will be a member of the bioanalytical and drug metabolism-pharmacokinetics (DMPK) team which develops bioanalytical assays for small molecule protein degrader quantification.  We are seeking an experienced and talented individual to provide organizational and scientific leadership in bioanalytical sciences supporting preclinical and clinical studies. As a subject matter expert, you will be responsible for the strategic planning and tactical execution of all aspects of regulated bioanalysis to support candidate development. The ideal candidate will represent their function on study and project teams and will ensure the successful delivery of critical assays and results and be responsible for developing innovative, high-quality clinical bioanalytical methods, participating in assay transfer, and troubleshooting activities at external vendors.  Working collaboratively with colleagues in Early Discovery, Translational Sciences, and Clinical Development, you will design and provide for the execution of bioanalytical methods and successfully deliver bioanalytical results for PK/PD, toxicology, and clinical studies, while adhering to relevant regulatory guidelines.  You will also serve on cross-functional Project Teams, prepare relevant sections of regulatory filings, and may participate in interactions with global health authorities. 

This position operates within a fast-paced interdisciplinary environment, therefore good communication, flexibility and organization are required. The successful candidate will be responsible for:

  • Drive alignment with project teams, functional leadership, and governance committees on bioanalytical strategies and resourcing for regulated small molecule and biomarker bioanalysis.
  • Provide oversight of bioanalytical CROs to facilitate the transfer, development, and validation of regulated (GLP/GCP) bioanalytical methods and ensure quality data and reports are delivered within specified timelines. Manage CRO contracts and bioanalytical aspects of project budgets.
  • Contribute to the preparation of study protocols, reports, and bioanalytical sections of regulatory submissions (e.g., IND, NDA, BLA) and address relevant queries from regulatory agencies.
  • Interface with stakeholders including nonclinical development, translational sciences, clinical development, and external CROs to define and deliver upon strategies to support project timelines across multiple projects.
  • Experience in developing and qualifying internal methods and transferring to CRO’s for late-stage development support is a requirement. The position requires strong expertise in FDA/EMA, GLP/GCP regulatory requirements and Clinical bioanalytical data management (both GLP and non-GLP) including data transferring, analysis, and reporting.
  • Perform method development for potential small and large molecules using LC-MS/MS, hybrid LC-MS/MS, as required.

Qualifications & Experience:

  • Master’s degree in Biochemistry, Analytical Chemistry, or Pharmaceutics and Pharmacology with at least 8 years of industry experience, or Ph.D. degree in Biochemistry, Analytical Chemistry, or Pharmaceutics and Pharmacology with at least 5 years of industry experience.
  • A minimum of 10 years of experience in the pharmaceutical industry supporting bioanalysis in non-clinical and clinical studies.
  • Extensive experience developing and validating bioanalytical and methods for small molecules
  • Experience with authoring study plans, reports, and preparing bioanalytical sections of regulatory submission documents (e.g., IND, NDA/BLA) and bioanalytical components of nonclinical and clinical study protocols.
  • Strong knowledge in GLP/GCP regulations and regulatory guidance documents that apply to bioanalysis.

Fit with Nurix Culture and Values

  • Strong team orientation; highly collaborative
  • Solutions and results-oriented focus
  • Hands-on approach; resourceful and open to diverse points of view

Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.