Associate Director, Chemical Engineering (Drug Substance)

Nurix, Inc.; California (MO); Hybrid; USD 190,000 - 217,000; Full time

Job summary

Nurix Therapeutics in Brisbane, CA is seeking an Associate Director, Chemical Engineering to provide end-to-end engineering leadership for bexobrutideg DS from late-stage development through commercial launch, including oversight of CDMOs.

You will collaborate with the CMC team to drive process understanding, scale-up, tech transfer, and ensure cGMP compliance, quality and regulatory readiness across manufacturing sites and partner networks.

Qualifications

• Ph.D. in chemical engineering, or related field with at least 5 years (M.S. with 10 years or B.S. with 15 years) of industrial, late‑phase, small‑molecule drug substance development experience.
• Extensive GMP drug substance manufacturing, characterization, process development, equipment evaluation/selection, scale up and process validation.
• Knowledge of solid‑state properties, polymorphism, and crystallization principles relevant to small‑molecule drug substance.
• Extensive third‑party drug substance CDMO management experience including tech transfer activities, QbD and DoE studies, clinical supply production, registration batch production and commercial launch activities.
• In‑depth knowledge of relevant cGMP, ICH, FDA and EMA guidelines.
• Proven track record of effective internal and external collaboration.
• Excellent oral and written communication skills, interpersonal skills and problem‑solving abilities.
• Ability to multi‑task, manage conflict and work in a fast‑paced environment.
• Ability to travel up to 25% of their time.

Responsibilities

• Provide engineering leadership to design, develop and optimize scalable routes for small‑molecule DS manufacturing, including demonstrated knowledge in unit operation design, process modeling, process equipment selection and scale‑up methodologies.
• Review equipment configurations, qualification packages, and maintenance records at CDMOs to ensure equipment trains are properly qualified, maintained and operating at optimal performance to support Nurix manufacturing operations.
• Oversee equipment engineering and scale‑up operations at DS CDMOs, including hands‑on process troubleshooting during engineering, clinical, registration and PPQ batches.
• Lead technology transfer to CDMOs including scale‑up and demonstration of new chemical processes in development and commercial equipment.
• Coordinate with CDMOs and Nurix Quality Assurance, and Global Supply Chain functions to ensure timely manufacture and release of DS lots.
• Partner within Nurix CMC to drive process understanding (critical process parameters, critical quality attributes, control strategy) using engineering principles, DoE and QbD concepts.
• Review and approve Master Batch Records, campaign reports, deviation investigations and change controls for drug substance operations.
• Ensure manufacturing operations adhere to company quality, safety and regulatory standards (FDA, EMA, ICH, cGMP).
• Provide regular Person‑In‑Plant support for DS manufacturing and ongoing performance monitoring of key facility and operational KPIs acrossmanufacturing sites, including schedule adherence, batch performance, deviation trends, and inspection readiness.
• Author and review CMC sections of regulatory filings including INDs/IMPD, and NDA/MAA, including responses to Health Authority queries.
• Define and drive the long‑term engineering strategy for bexobrutideg DS, including process robustness, lifecycle management, and cost‑of‑goods optimization.
• Represent Chemical Engineering on CMC and cross‑functional program teams, providing input to development strategy, risk assessments, and timelines.
• Manage and provide technical mentorship of scientists and engineers.

Education

PhD in Chemical Engineering

Industrial, late-stage small-molecule drug substance development experience

Job description

Nurix Therapeutics in Brisbane, CA is seeking an Associate Director, Chemical Engineering to provide end-to-end engineering leadership for bexobrutideg DS from late-stage development through commercial launch, including oversight of CDMOs.

You will collaborate with the CMC team to drive process understanding, scale-up, tech transfer, and ensure cGMP compliance, quality and regulatory readiness across manufacturing sites and partner networks.