Principal Engineer, Pharmaceutical Development
- Salary
- ₹18–30 LPA
- Location
- Brisbane
- Experience
- Senior
About the company & role
Principal Engineer, Pharmaceutical Development Engineering 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. Position Description The Opportunity Provide engineering leadership for small-molecule drug product manufacturing process development and optimization to facilitate process transfer to CDMOs and scale-up. 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. Coordinate with CDMOs and Nurix QA, Chemical Development, and Global Supply Chain functions to ensure timely manufacture and release of DP lots. Partner with Nurix Chemical Development and Analytical Development Quality Control to identify critical process parameters of associated equipment and facility, and overall control strategies. Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Nurix policies and procedures. 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. Support operational execution related to equipment scheduling, manufacturing, and coordination, supporting both clinical and commercial production requirements. Write and review CMC sections of regulatory filings, including INDs, IND amendments, and NDAs. Ensure all equipment trains at CDMOs are properly qualified, maintained, and operating at optimal performance to support Nurix manufacturing operations. Provide technical mentorship and guidance to scientists and engineers. What You’