Director, Small Molecule Development & Scale-Up

jobr.pro

Brisbane (CA)

On-site

USD 218,000 - 260,000

Full time

14 days+

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Benefits offered by this job

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Job summary

Nurix Therapeutics, Inc. in Brisbane, CA seeks a Director of Pharmaceutical Development to lead small molecule drug product development for oral and topical forms.

You will guide QbD-based formulation, process development, and tech transfer from early phase to commercial launch, while coordinating cross‑functional teams and external CDMOs. The role requires 12+ years of industry experience, strong CMC/regulatory submission expertise, and leadership capabilities, with travel ~25% and GMP

Qualifications

  • Ph.D. and 12+ years of industry pharma development experience.
  • Deep expertise in small molecule drug product for oral/topical forms.
  • Strong QbD knowledge: QTPP, CQA, CMA/CPP risk assessment, DoE, design space.
  • Late-stage development (Phase 2b/3) and NDA/MAA experience required.
  • Experience authoring/regulatory submissions (INDs/NDAs/CTDs) and CDMO oversight.
  • People management at department level; budget/resource ownership.
  • Willingness to travel ~25% and perform in cleanroom GMP settings.

Responsibilities

  • Lead formulation and process development for small molecule programs across all phases.
  • Apply amorphous solid dispersions, lipid-based systems, and nano-formulations to solve solubility issues.
  • Define QTPP and CQAs; identify CMAs/CPPs using risk tools.
  • Scale up manufacturing and transfer tech to pilot and commercial scales.
  • Drive late-stage regulatory activities and PPQ/CPV processes.
  • Manage external CDMO partnerships and cross-functional teams; mentor staff.

Skills

QbD methodologies
DoE
CMC regulatory submissions
CDMO management
Cross-functional leadership
Program management

Education

Ph.D. in Pharmaceutical Sciences / Pharmaceutics / Chemical Engineering / Chemistry

Job description

Nurix Therapeutics, Inc. in Brisbane, CA seeks a Director of Pharmaceutical Development to lead small molecule drug product development for oral and topical forms.

You will guide QbD-based formulation, process development, and tech transfer from early phase to commercial launch, while coordinating cross‑functional teams and external CDMOs. The role requires 12+ years of industry experience, strong CMC/regulatory submission expertise, and leadership capabilities, with travel ~25% and GMP

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