Associate Director, Chemical Eng: DS Scale-Up & Tech Transfer

Initial Therapeutics, Inc.; Brisbane (CA); On-site; USD 190,000 - 217,000; Full time

Benefits offered by this job

Salary range included in posting

Job summary

Nurix Therapeutics is seeking an Associate Director, Chemical Engineering to lead end-to-end DS manufacturing support for bexobrutideg (NX-5948) from late-stage development through commercial launch, with oversight of CDMOs. The role reports to the Director, Chemical Development and partners with CMC, QA, and Supply Chain.

You will direct engineering design, scale-up, tech transfer, process understanding, and lifecycle management while ensuring compliance with cGMP, ICH, FDA and EMA guidelines,

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.

Responsibilities

• 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 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 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.

Skills

Process modeling

Scale-up design

CDMO management

Tech transfer

QbD & DoE

GMP knowledge

Regulatory awareness

Team mentorship

Cross-functional collaboration

Education

Ph.D. in Chemical Engineering

Job description

Nurix Therapeutics is seeking an Associate Director, Chemical Engineering to lead end-to-end DS manufacturing support for bexobrutideg (NX-5948) from late-stage development through commercial launch, with oversight of CDMOs. The role reports to the Director, Chemical Development and partners with CMC, QA, and Supply Chain.

You will direct engineering design, scale-up, tech transfer, process understanding, and lifecycle management while ensuring compliance with cGMP, ICH, FDA and EMA guidelines,