Senior Scientist, Drug Product Analytics & Quality Control

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

Job summary

The ideal candidate has advanced degrees and 8+ years (PhD) or 14+ years (BS/MS) in CMC, plus strong cross-functional and communications skills to drive late-stage programs.

Qualifications

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

Responsibilities

• Lead analytical method development validation and lifecycle management for drug product formulations.
• Oversee DP development, PPQ activities, and stability programs.
• Author and review analytical development reports for regulatory submissions.
• Support regulatory submissions and health authority responses.
• Collaborate with cross-functional teams to ensure alignment of analytical and QC strategies.

Skills

Analytical method development

CDMO oversight

Regulatory submissions

Cross-functional collaboration

Technical writing

Data integrity

cGMP knowledge

Education

Advanced degree in Chemistry, Pharmaceutics, or related field

PhD with 8+ years or BS/MS with 14+ years CMC experience

Job description

The ideal candidate has advanced degrees and 8+ years (PhD) or 14+ years (BS/MS) in CMC, plus strong cross-functional and communications skills to drive late-stage programs.