Principal Engineer, Pharmaceutical Development
NurixAbout the role
<p><span style="font-size: 12pt;"><strong>Principal Engineer, Pharmaceutical Development Engineering</strong></span></p> <p><em>Own the hands-on engineering that turns a promising molecule into a manufacturable drug product — leading process development, scale-up, and CDMO operations for Nurix's late-stage clinical and commercial programs. This is a highly technical, high-autonomy role with direct impact on getting real treatments to patients.</em></p> <p><strong>Position Description</strong></p> <p><strong>The Opportunity</strong></p> <ul> <li>Provide engineering leadership for small-molecule drug product manufacturing process development and optimization to facilitate process transfer to CDMOs and scale-up.</li> <li>Lead equipment engineering and operations at drug product CDMOs, including technology transfer, CTM production, process troubleshooting, QBD, DOEs and PAR studies, registration batch production, and process validation.</li> <li>Coordinate with CDMOs and Nurix QA, Chemical Development, and Global Supply Chain functions to ensure timely manufacture and release of DP lots.</li> <li>Partner with Nurix Chemical Development and Analytical Development & Quality Control to identify critical process parameters of associated equipment and facility, and overall control strategies.</li> <li>Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Nurix policies and procedures.</li> <li>Provide Person-In-Plant support for drug product manufacturing and ongoing performance monitoring of key facility and operational KPIs across manufacturing sites, including schedule adherence, batch performance, deviation trends, and inspection readiness.</li> <li>Support operational execution related to equipment scheduling, manufacturing, and coordination, supporting both clinical and commercial production requirements.</li> <li>Write and review CMC sections of regulatory filings, including INDs, IND amendments, and NDAs.</li> <li>Ensure all equipment trains at CDMOs are properly qualified, maintained, and operating at optimal performance to support Nurix manufacturing operations.</li> <li>Provide technical mentorship and guidance to scientists and engineers.</li> </ul> <p><strong>What You’ll Bring</strong></p> <ul> <li>Ph.D. in chemical engineering or a related field with at least 8 years (M.S. with 12 years, or B.S. with 16 years) of industrial, late-phase, small-molecule drug product development experience.</li> <li>Extensive knowledge and experience in GMP oral solid dose form manufacturing (spray drying, tableting, and encapsulation), characterization, process development, equipment evaluation/selection, scale-up, and process va
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