Associate Director, Chemical Engineering

NURIX; San Francisco (CA); Vor Ort; USD 190.000 - 217.000; Vollzeit

Zusammenfassung

Nurix Therapeutics in Brisbane, CA is seeking an Associate Director, Chemical Engineering to provide end-to-end DS manufacturing leadership for bexobrutideg (NX-5948) from late-stage development through commercial launch.

You will lead scalable DS routes, oversee CDMO equipment qualification, drive tech transfer, and ensure cGMP compliance while partnering with CMC teams to optimize process robustness and cost of goods.

Qualifikationen

• PhD in chemical engineering with 5+ years in late-stage DS development.
• Extensive GMP DS manufacturing, scale-up, and validation experience.
• Knowledge of solid-state properties, polymorphism, crystallization.
• CDMO management experience including tech transfer and DoE/QbD.

Aufgaben

• Lead design and scale-up of DS manufacturing routes.
• Oversee CDMO equipment qualification and maintenance.
• Coordinate tech transfer to CDMOs and QA/QC.
• Support regulatory CMC sections and Health Authority responses.
• Monitor KPIs and ensure on-time manufacturing and release.

Kenntnisse

Engineering leadership

Process modeling

Scale-up

DoE

QbD

CDMO management

Regulatory knowledge

GMP familiarity

Cross-functional collaboration

Ausbildung

Ph.D. in chemical engineering

MS in chemical engineering

BS in chemical engineering

Tools

GMP systems

DoE software

Process modeling tools

Jobbeschreibung

Associate Director, Chemical Engineering

Brisbane, California, United States

Associate Director, Chemical Engineering

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Position Description

Nurix 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 leadershipand 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.

• 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.

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