Associate Director, Chemical EngineeringNurix is seeking an experienced, independent, and highly motivated individual who will be accountable for end-to-end chemical engineering support of bexobrutideg (NX-5948) drug substance (DS) from late-stage 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 leadership and 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 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 across manufacturing 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.
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 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.
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: $189,800 - $216,700
Location: Brisbane, CA - Onsite
