Principal Engineer, Pharmaceutical Development

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’ll Bring 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. 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 validation. Extensive third-party drug product CDMO management experience, including tech transfer activities, QBD and DOE studies, clinical supply production, registration batch production, and commercial launch activities. Knowledge and understanding of product/packaging interactions, barrier properties, stability, global pharmaceutical packaging regulations, and package testing. In-depth knowledge of relevant cGMP, ICH, FDA, and EMA guidelines. Proven track record of effective internal and external collaboration. Excellent Oral/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 time. Salary Range $195,300 - 222,900 The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements. Location

Onsite: Brisbane, CA