Associate Director, Chemical Engineering

Associate Director Chemical Engineering

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery development and commercialization of targeted protein degradation medicines the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class and coupled with unparalleled ligase expertise Nurixs dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care writing medicines next chapter with a new script to outmatch disease.

Position Description

Nurix is seeking an experienced independent and highly motivated individual who will be accountable for endtoend chemical engineering support of bexobrutideg (NX-5948) drug substance (DS) from latestage development through commercial launch including oversight of external manufacturing sites. The Associate Director Chemical Engineering will work closely with the CMC team and colleagues in cross-functional departments to provide scientific technical and hands-on leadershipand oversight of facility and equipment operations at Contract Development Manufacturing Organizations (CDMOs) to support bexobrutideg drug substance manufacturing process optimization and scale-up. The position will report to the Director Chemical Development.

Responsibilities will include but are not limited to:

• 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 handson 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 longterm engineering strategy for bexobrutideg DS including process robustness lifecycle management and costofgoods optimization.
• Represent Chemical Engineering on CMC and crossfunctional program teams providing input to development strategy risk assessments and timelines.
• Manage and provide technical mentorship of scientists and engineers.

Required 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 knowledge and experience in GMP drug substance manufacturing characterization process development equipment evaluation/selection scale up and process validation.
• Knowledge of solidstate properties polymorphism and crystallization principles relevant to smallmolecule 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.

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

Salary Range: $189800 - $216700

Location: Brisbane CA - Onsite