Ph.D. in chemical engineering or related field with 8+ years of experience (M.S. with 12 years, B.S. with 16 years) in late-phase small-molecule drug development.
Extensive knowledge in GMP oral solid dose manufacturing, including spray drying, tableting, and encapsulation.
Proven experience managing third-party CDMO operations, including tech transfer and clinical supply production.
Strong understanding of product/packaging interactions and global pharmaceutical packaging regulations.
In-depth knowledge of cGMP, ICH, FDA, and EMA guidelines.
Responsibilities
Lead engineering for small-molecule drug product manufacturing process development and optimization.
Oversee equipment engineering and operations at CDMOs, including technology transfer and process validation.
Coordinate with CDMOs and internal teams to ensure timely manufacture and release of drug product lots.
Identify critical process parameters and control strategies in collaboration with Chemical and Analytical Development teams.
Monitor key performance indicators across manufacturing sites, ensuring adherence to schedules and quality standards.
Support operational execution related to equipment scheduling and manufacturing for clinical and commercial needs.
Write and review CMC sections of regulatory filings, including INDs and NDAs.
Benefits
Collaborative and team-oriented work environment.
Focus on solutions and results, promoting a hands-on approach.
Opportunity for technical mentorship and guidance within the team.
Full Job Description
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
Nurix Therapeutics is a biotechnology company that is focused on the discovery, development, and commercialization of small molecule therapies that modulate the ubiquitin proteasome system (UPS) for the treatment of cancer and other diseases. The company's proprietary drug discovery platform is based on the use of DNA-encoded libraries (DELs) to identify small molecules that selectively bind to E3 ligases, which are key enzymes in the UPS. Nurix's lead drug candidate, NX-2127, is a first-in-class small molecule inhibitor of the CBL-B E3 ligase that is being developed for the treatment of solid tumors and hematological malignancies. The company was founded in 2013 and is headquartered in San Francisco, California.
