Director, Pharmaceutical Development
Nurix Therapeutics
August 22, 2026
On-site
Brisbane, CA
Clinical Research and Development
Responsibilities:
- Lead QbD-based formulation and process development for small molecule oral and topical drug programs across all development phases.
- Apply BCS Class II/IV formulation expertise (amorphous solid dispersions via spray-dried dispersions/hot-melt extrusion, lipid-based systems such as SMEDDS/SEDDS/lipid suspensions, and nano-formulations).
- Define QTPP and identify CQAs; perform FMEA-based risk assessments to identify CMAs and CPPs.
- Develop/optimize scalable, robust manufacturing processes.
- Lead tech transfer/scale-up from lab to pilot/commercial; troubleshoot deviations/OOS failures and drive RCA and CAPA.
- Drive Phase 2b–commercial activities (clinical supply manufacturing, PPQ, CPV) and author/review CMC sections for INDs/NDAs/MAAs.
- Ensure GMP and internal quality compliance.
- Manage CDMO partnerships (vendor qualification, technical oversight, performance governance); serve as technical point of contact across functions; mentor team.
Requirements:
- Ph.D. (strongly preferred) in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering/Chemistry (or related) with 12+ years industry experience; 12+ years progressive pharmaceutical development in industry (biotech/pharma/CDMO).
- Deep small-molecule oral/topical and enabled formulation experience.
- Hands-on QbD: QTPP/CQA, CMA/CPP risk assessment, DoE/design space, and control strategy.
- Late-stage (Phase 2b/3) and NDA/MAA submission experience required.
- Proven CMC author/reviewer track record and agency query responses.
- Direct CDMO management experience.
- Knowledge of lifecycle management, post-approval changes, and SUPAC.
- Director level: people management, strategic planning, and budget/resource ownership.
- Office/lab environment; occasional GMP access; ~25% travel; must gown for cleanroom/GMP.
Salary Range: $218,000–$260,000
Location: On site in Brisbane, CA office.
- Lead QbD-based formulation and process development for small molecule oral and topical drug programs across all development phases.
- Apply BCS Class II/IV formulation expertise (amorphous solid dispersions via spray-dried dispersions/hot-melt extrusion, lipid-based systems such as SMEDDS/SEDDS/lipid suspensions, and nano-formulations).
- Define QTPP and identify CQAs; perform FMEA-based risk assessments to identify CMAs and CPPs.
- Develop/optimize scalable, robust manufacturing processes.
- Lead tech transfer/scale-up from lab to pilot/commercial; troubleshoot deviations/OOS failures and drive RCA and CAPA.
- Drive Phase 2b–commercial activities (clinical supply manufacturing, PPQ, CPV) and author/review CMC sections for INDs/NDAs/MAAs.
- Ensure GMP and internal quality compliance.
- Manage CDMO partnerships (vendor qualification, technical oversight, performance governance); serve as technical point of contact across functions; mentor team.
Requirements:
- Ph.D. (strongly preferred) in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering/Chemistry (or related) with 12+ years industry experience; 12+ years progressive pharmaceutical development in industry (biotech/pharma/CDMO).
- Deep small-molecule oral/topical and enabled formulation experience.
- Hands-on QbD: QTPP/CQA, CMA/CPP risk assessment, DoE/design space, and control strategy.
- Late-stage (Phase 2b/3) and NDA/MAA submission experience required.
- Proven CMC author/reviewer track record and agency query responses.
- Direct CDMO management experience.
- Knowledge of lifecycle management, post-approval changes, and SUPAC.
- Director level: people management, strategic planning, and budget/resource ownership.
- Office/lab environment; occasional GMP access; ~25% travel; must gown for cleanroom/GMP.
Salary Range: $218,000–$260,000
Location: On site in Brisbane, CA office.