Senior Scientist, Analytical Development and Quality Control - Early Phase (Biopharma)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Location: Onsite at Nurix headquarters in Brisbane, California, United States; travel up to 5% may be required.
Salary: $162,000β$186,000 per year
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.
What you will do
- Lead analytical method development, validation, and lifecycle management for drug product formulations, including amorphous solid dispersions and lipid-based systems.
- Design and oversee development, registration batch, and commercial stability programs, including protocols, trend analysis, retest periods, and shelf-life assessments.
- Provide technical oversight of analytical development, validation, and QC testing performed by CDMOs and contract testing laboratories.
- Support PPQ, commercialization, commercial QC, late-phase technology transfer, and analytical control strategies.
- Author and review analytical development reports, specifications, validation and stability documents, certificates of analysis, and storage statements.
- Contribute to investigations, root-cause analysis, CAPAs, regulatory submissions, health-authority responses, data integrity, and inspection readiness.
Requirements
- Advanced degree in chemistry, pharmaceutics, or a related discipline.
- BS/MS with 14+ years or PhD with 8+ years of industrial CMC experience.
- Strong experience in drug product analytical development and validation, including chromatographic and dissolution methods.
- Experience with amorphous solid dispersions and/or lipid-based formulations, CDMO oversight, and contract testing laboratories.
- Experience supporting IND, IMPD, NDA, and global regulatory filings.
- Fluency with ICH guidelines, cGMP requirements, pharmacopeial chapters, technical writing, and cross-functional collaboration.
Culture & Benefits
- Work in multidisciplinary teams spanning Chemical Development, Pharmaceutical Development, Regulatory, Quality, Preclinical, Supply Chain, Medicinal Chemistry, and DMPK.
- Operate in a fast-paced environment while managing multiple priorities.
- Follow cGMP requirements and internal SOPs.
- Maintain organized analytical documentation and data for traceability, data integrity, and inspection readiness.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β