Senior Scientist, Drug Product Analytics & QC

BioSpace

Brisbane (CA)

On-site

USD 162,000 - 186,000

Full time

14 days+
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Job summary

Nurix Therapeutics is seeking a Senior Scientist to join the Analytical Development and Quality Control group in Brisbane, CA. The role focuses on drug product analytical development, method development, and lifecycle management with external CDMOs and CRO partners. You will author development reports and support IND/IMPD/NDA submissions.

You will lead method validation, support late‑phase transfer, and contribute to analytical strategies across development stages in a fast-paced environment.

Qualifications

  • Advanced degree in Chemistry, Pharmaceutics, or related field.
  • 14+ years with BS/MS or 8+ years with PhD in industrial CMC.
  • Experience with drug product analytical development and validation.
  • Experience with amorphous solid dispersions (ASDs) and/or lipid-based formulations.
  • Experience in CDMO/contract testing lab oversight.
  • Experience supporting regulatory submissions (IND/IMPD/NDA).
  • Fluency with ICH guidelines, cGMPs, and pharmacopeial chapters.

Responsibilities

  • Lead analytical method development, validation, and lifecycle management for drug product formulations.
  • Design and oversee DP development, registration batch, and stability programs.
  • Author and review analytical development reports for regulatory submissions.
  • Oversee activities at CDMOs and contract testing labs.
  • Investigate OOS/OOE/OOT and perform root cause analysis and CAPAs.
  • Collaborate with cross-functional teams to align analytical strategies.

Skills

Cross-functional collaboration
Strong technical writing
Analytical problem solving

Education

Advanced degree in Chemistry/Pharmaceutics

Job description

Nurix Therapeutics is seeking a Senior Scientist to join the Analytical Development and Quality Control group in Brisbane, CA. The role focuses on drug product analytical development, method development, and lifecycle management with external CDMOs and CRO partners. You will author development reports and support IND/IMPD/NDA submissions.

You will lead method validation, support late‑phase transfer, and contribute to analytical strategies across development stages in a fast-paced environment.

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