Director, Pharmaceutical Development

Responsibilities

• Lead QbD-based formulation and process development for small molecule drug programs focusing on oral and topical dosage forms
• Apply expertise in BCS Class II/IV compound development and enabling technologies like amorphous solid dispersions and lipid-based systems
• Define Quality Target Product Profiles (QTPP) and identify Critical Quality Attributes (CQAs)
• Conduct systematic risk assessments using FMEA to identify CMAs and CPPs
• Lead manufacturing scale-up activities from laboratory to pilot and commercial scale
• Drive late-stage development activities including clinical supply manufacturing and PPQ
• Author and review CMC sections of regulatory submissions such as INDs, NDAs, and MAAs
• Manage external CDMO partnerships, including technical oversight and performance governance
• Provide scientific leadership and mentorship to junior scientists and project team members

Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or related discipline
• 12+ years of progressive pharmaceutical development experience in industry
• Deep expertise in small molecule drug product development (oral and topical)
• Comprehensive hands-on experience with QbD methodologies and DoE
• Significant late-stage development experience (Phase 2b/3 and NDA/MAA submission)
• Proven track record of authoring/reviewing CMC regulatory submissions
• Direct CDMO management experience
• Demonstrated people management experience leading scientists and managers
• Ability to travel approximately 25% for CDMO and regulatory site visits
• Ability to gown for cleanroom/GMP environments

About the Company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines to improve treatment options for patients with cancer and inflammatory diseases.