Director, Small Molecule Drug Product Development

BioSpace; Brisbane (CA); Presencial; USD 218.000 - 260.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics, Inc. is seeking a highly experienced Director of Pharmaceutical Development to lead small molecule drug product development for oral and topical dosage forms.

Responsibilities span QbD-based formulation, process development, scale-up, and CDMO management, from early phase through commercial launch. The role requires deep expertise in late-stage development, CMC regulatory submissions, and cross-functional leadership across Analytical Development, Regulatory Affairs, and

Formación

• Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline strongly preferred with 12 years of industry experience.
• 12+ years of progressive pharmaceutical development experience in an industry setting (biotechnology, pharmaceutical, or CDMO).
• Deep expertise in small molecule drug product development with a focus on oral and topical dosage forms, especially enabled formulation development (e.g., amorphous solid dispersions, lipid‑based systems, nano‑formulations).
• Comprehensive hands‑on experience with QbD methodologies: QTPP definition, CQA identification, CMA/CPP risk assessment, DoE, design space development, and control strategy establishment.
• Significant late‑stage development experience (Phase 2b/3 and NDA/MAA submission) is required.
• Proven track record of authoring and/or reviewing CMC regulatory submissions (INDs, NDAs, CTDs) and successfully responding to agency queries.
• Direct CDMO management experience, including technical oversight, project governance, and relationship management.
• Knowledge of lifecycle management, post‑approval changes, and SUPAC guidance.
• For the Director level: demonstrated people management experience leading a team of scientists/managers, department‑level strategic planning, and budget/resource ownership across multiple concurrent programs.
• Primarily office and laboratory environment; occasional GMP manufacturing facility access required.
• Approximately 25% travel required, including domestic and international trips to CDMO sites, clinical manufacturing sites, regulatory agency meetings, and scientific conferences.
• Must be able to gown for cleanroom/GMP environments.

Responsabilidades

• Lead formulation & process development for small molecule programs with emphasis on oral and topical dosage forms across all development phases.
• Define and implement QbD strategies, QTPP, CQAs, CMA/CPP risk assessments, and developmental controls.
• Oversee scale-up, technology transfer, and process verification from lab to commercial scale; troubleshoot deviations.
• Drive late-stage development activities (Phase 2b through commercial launch), including clinical supply manufacturing and PPQ/CPV.
• Author/review CMC sections of regulatory submissions (INDs, NDAs, CTDs) and respond to agency queries.
• Manage external CDMOs, ensure timelines, quality, and budget adherence; mentor junior scientists.

Conocimientos

Scientific leadership

Cross-functional collaboration

Project management

Strategic thinking

People development

Communication

CDMO management

Cleanroom gowning

Educación

PhD in Pharmaceutical Sciences or related

Descripción del empleo

Nurix Therapeutics, Inc. is seeking a highly experienced Director of Pharmaceutical Development to lead small molecule drug product development for oral and topical dosage forms.

Responsibilities span QbD-based formulation, process development, scale-up, and CDMO management, from early phase through commercial launch. The role requires deep expertise in late-stage development, CMC regulatory submissions, and cross-functional leadership across Analytical Development, Regulatory Affairs, and