Director, Pharmaceutical Development

• Lead manufacturing scale-up activities from laboratory to pilot and commercial scale, ensuring robust and reproducible processes.
• Troubleshoot manufacturing deviations, out-of-specification results, and process failures; drive root cause analysis and implement corrective actions.

• Drive late-stage development activities (Phase 2b through commercial launch) including clinical supply manufacturing, process performance qualification (PPQ), and continued process verification (CPV).
• Author and review CMC sections of regulatory submissions including INDs, NDAs, and MAAs.
• Ensure all development activities comply with current GMP regulations and internal quality standards.

• Manage external CDMO partnerships, including vendor qualification, technical oversight, and performance governance to ensure project timelines, quality standards, and budget commitments are met.
• Serve as the primary technical point of contact between pharmaceutical development and cross-functional teams including Analytical Development, Clinical Operations, Regulatory Affairs, Quality, Supply Chain, and Commercial.
• Provide scientific leadership and mentorship to junior scientists, associates, and project team members.

• 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

• Scientific Leadership — Recognized internal and external thought leader in pharmaceutical development; drives scientific innovation and excellence.
• Strategic Thinking — Ability to anticipate technical and regulatory risks and develop proactive mitigation strategies that protect project timelines.
• Cross-Functional Collaboration — Demonstrated ability to build strong working relationships and influence without authority across diverse internal and external stakeholders.
• Project Management — Experienced in managing multiple complex projects simultaneously in a fast-paced, deadline-driven environment.
• Communication — Exceptional written and verbal communication skills; able to present complex scientific data clearly to both technical and non-technical audiences, including senior leadership and regulatory agencies.
• People Development — Commitment to mentoring and developing scientific talent within the organization.

Range: 218K – 260K plus bonus and equity.

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package.

Applicants should be legally entitled to work for any employer in the US.

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