Senior Scientist, Analytical Development & QC for INDs

BioSpace; Brisbane (CA); On-site; USD 162,000 - 186,000; Full time

Job summary

Nurix Therapeutics seeks an experienced Senior Scientist to lead Analytical Development and Quality Control activities for IND-enabling and early phase studies. The Senior Scientist will develop analytical test methods, characterize drug substance and drug product attributes, identify and characterize technical risk, and collaborate in risk mitigation work.

The ideal candidate must have expertise in chromatographic method development, stability studies, and phase-appropriate validation and

Qualifications

• BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
• Expertise in HPLC method development.
• Experience managing analytical activities at CDMOs/CROs.
• Strong knowledge of ICH guidelines and cGMPs.
• Ability to interpret data and communicate technical concepts.

Responsibilities

• Characterization of drug substance and drug product attributes, identification of technical risks, and collaboration towards risk mitigation strategy.
• Method development for and analytical characterization of drug substances, drug products, and product stability.
• Management and/or execution of method development internally and at CDMOs/CTLs.
• Management of method validation, QC testing, and reference standards at CDMOs/CTLs.
• Management of forced degradation, long term stability, and predictive stability studies.
• Contribution to OOS/OOE/OOT investigations.
• Critical review of data, protocols, reports, specifications, and other documentation.
• Trending stability data and establishing retest periods/shelf life using statistical methods.
• Collaboration in the development of material control strategies and specifications.
• Follow cGMP requirements and internal SOPs

Skills

HPLC method development

Analytical method development

CDMO management

Data interpretation

Interpersonal skills

Education

BS/MS with 14+ years or PhD with 8+ years in industrial CMC

Tools

Gas chromatography

NMR

Mass spectrometry

ICP-MS/OES

FTIR

Dissolution testing

Job description

Nurix Therapeutics seeks an experienced Senior Scientist to lead Analytical Development and Quality Control activities for IND-enabling and early phase studies. The Senior Scientist will develop analytical test methods, characterize drug substance and drug product attributes, identify and characterize technical risk, and collaborate in risk mitigation work.

The ideal candidate must have expertise in chromatographic method development, stability studies, and phase-appropriate validation and