Scientist I/Scientist II, Analytical Development, CMC

Location
San Francisco, CA, United States
Posted
Jul 04, 2021
Ref
5310620002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
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.

Summary

Reporting to the Director, Analytical Development of CMC, Scientist I/Scientist II Analytical Development will be responsible for providing hands-on analytical support of pre-clinical and clinical development of small molecule pharmaceuticals. This will include generating analytical data for method development/validation/transfer, impurity purification and characterization, working closely with CROs/CMOs, review of data/protocols/reports from CROs/CMOs, maintenance of laboratory and analytical instruments. The candidate should be self-driven, innovative, detail oriented and thorough in performing a range of novel tasks.

Essential duties and responsibilities include but are not limited to the following
  • Develop robust and sensitive analytical methods for drug substances (DS), drug products (DP), intermediates and starting materials of small molecule therapeutics.
  • Review method validation protocols and reports, primary analytical data and development reports from CROs/CMOs.
  • Oversight of method transfers from Nurix to CROs/CMOs or between CROs/CMOs
  • Oversight of external stability testing of DS and DP to ensure that the data support ongoing and proposed clinical studies, including establishment and review of protocols and reports and associated primary data
  • Manage supplies of reference standards, including coordinating qualification and retest
  • Work closely with process leads and scientists from MedChem and BioAnalysis to develop methodologies for impurity purification, identification and characterization.

Required Qualifications
  • Bachelor's degree in analytical chemistry or related disciplines with a minimum of 12 years of experience, or master's degree with a minimum of 8 years of experience in small-molecule analytical development.
  • Extensive hands-on experience in and in-depth knowledge of various analytical techniques: Liquid chromatography, especially UPLC (Reverse phase, chiral, ion exchange, ion pairing, etc.) with various detectors including charged aerosol detectors (CAD); Mass spectrometry (QDa, QQQ and QTof); Gas chromatography (GC-MS and GC-FID), dissolution, KF and NMR spectroscopy
  • Extensive experience in method development, validation and transfer for release testing, stability testing and in-process control of drug substance and drug products.
  • Hands-on experience in purification using tools such as semi-preparative HPLC and SFC (supercritical fluid chromatography).
  • Experience with physical characterization techniques, such as XRPD, DSC, BET and PSD, will be a plus.
  • Familiarity with operating in a GMP environment, and a thorough knowledge of FDA, ICH, USP and EP Guidelines as well as current best-practices in the Industry.
  • A team player with excellent communication skills.

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.