Principal Engineer, Pharmaceutical Development

Nurix Therapeutics; United States; Presencial; USD 195.000 - 223.000; Jornada completa

Descripción de la vacante

Nurix Therapeutics is seeking a Principal Engineer, Pharmaceutical Development Engineering, to own hands-on engineering that turns a promising molecule into a manufacturable drug product. You will lead DP development, scale-up, tech transfer to CDMOs, and process validation for clinical and commercial programs.

You will partner across QA, Chemical Development, and Global Supply Chain to ensure timely DP manufacture and release, while maintaining compliance with FDA/EMA/cGMP guidelines.

Formación

• Ph.D. in chemical engineering with extensive industrial, late-phase, small-molecule drug product development experience.
• Strong knowledge of GMP oral solid dose form manufacturing and related processes.
• Experience managing third-party CDMO tech transfer, QBD/DOE studies, and regulatory manufacturing.
• Understanding of product/packaging interactions, stability, packaging regulations, and testing.

Responsabilidades

• Provide engineering leadership for small-molecule DP development and optimization.
• Lead equipment engineering and operations at DP CDMOs, including tech transfer and process validation.
• Coordinate with QA, Chemical Development, and Global Supply Chain to ensure DP lot release.
• Write and review CMC sections of regulatory filings and ensure proper equipment qualification.

Conocimientos

GMP knowledge

Process development

Tech transfer

Project leadership

Cross-functional leadership

Educación

Ph.D. in chemical engineering

M.S. in chemical engineering

Herramientas

QBD

DOEs

Process validation

Descripción del empleo

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’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

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

About Nurix Therapeutics

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.