Senior Scientist, Analytical Development and Quality Control - Early Phase

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

Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease.

Position

Nurix Therapeutics seeks an experienced Senior Scientist to join the Analytical Development and Quality Control group. The Senior Scientist will lead analytical and QC activities in IND-enabling and early phase clinical 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 Senior Scientist will oversee and execute analytical development, validation, and testing both internally and at external CDMO/CRO partners and author relevant sections of regulatory filings.

The ideal candidate must have expertise in chromatographic method development, stability studies, and phase-appropriate validation and control. The ideal candidate should have a record of contribution to first-in-human INDs and experience in vendor oversight.

This position is onsite at Nurix headquarters in Brisbane, CA.

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

Qualifications

• Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field)
• Senior Scientist: BS/MS degree with 14+ years or PhD with 8+ years of industrial CMC experience
• Expertise in HPLC method development is essential
• Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR
• Experience in analytical method development and validation
• Experience in management of analytical activities at CDMOs/CROs
• Solid understanding of control strategy, method validation, and retest/expiry
• Experience managing stability programs, reference standards, and retest/expiry
• Familiarity with ICH guidelines, cGMPs, and pharmacopeial chapters
• Familiarity with deviation management and change control
• Ability to critically interpret data and articulate technical concepts in multidisciplinary settings
• Ability to ensure assigned activities are completed in satisfaction of project timelines
• Strong interpersonal skills that foster collaboration within and outside of the organization
• Ability to travel domestically and internationally
• 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

Salary Range: $162K - $186K