Senior Director, Quality Control

Nurix; Brisbane (CA); Vor Ort; USD 190.000 - 230.000; Vollzeit

Zusammenfassung

Nurix Therapeutics seeks an Associate Director of Chemical Engineering to lead end‑to‑end DS manufacturing for bexobrutideg (NX-5948) from late‑stage development through launch, overseeing CDMOs and coordinating with the CMC team and QA. This hands‑on role drives process scale‑up, tech transfer, and regulatory readiness.

You will mentor scientists, optimize scale‑up strategies, ensure cGMP compliance, and contribute to strategic planning for lifecycle management and cost‑of‑goods optimization.

Qualifikationen

• 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.

Aufgaben

• 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 across manufacturing 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.

Kenntnisse

CDMO management

Process development

Scale-up

Tech transfer

DoE

QbD concepts

GMP knowledge

Regulatory knowledge

Cross-functional leadership

Troubleshooting

Ausbildung

Ph.D. in chemical engineering

Jobbeschreibung

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 leadership and 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.

Responsibilities will include but are not limited to:

• 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 across manufacturing 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 op