Principal Engineer, Pharmaceutical Development

BioSpace

Brisbane (CA)

On-site

USD 195,000 - 223,000

Full time

16 hours ago
Be an early applicant
Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

Nurix Therapeutics seeks a Principal Engineer to own hands-on process development for small-molecule drug product manufacturing, leading scale-up and CDMO operations for late-stage and commercial programs. You will drive technology transfer, QBD/DOE studies, and regulatory batch activities with QA, Chemical Development, and Global Supply Chain partners.

Applicants should have a Ph.D. in chemical engineering (or equivalent) with 8+ years of industry experience in GMP DP development, CDMO

Qualifications

  • Ph.D. in chemical engineering or related field with at least 8 years of industrial, late-phase, small-molecule drug product development experience.
  • Extensive GMP oral solid dose form manufacturing knowledge (spray drying, tableting, encapsulation).
  • Extensive third-party drug product CDMO management experience, including tech transfer, QBD and DOE studies, clinical supply, registration batches, and commercial launches.

Responsibilities

  • Provide engineering leadership for small-molecule drug product process development and optimization for CDMOs and scale-up.
  • Lead equipment engineering and operations at drug product CDMOs, including technology transfer and process validation.
  • Coordinate with CDMOs and Nurix QA, Chemical Development, and Global Supply Chain for timely DP manufacture and release.

Skills

Process development leadership
Scale-up
CDMO management
QBD
DOE studies
Regulatory knowledge
GMP experience
Technical mentorship
Cross-functional collaboration

Education

Ph.D. in chemical engineering
M.S. in chemical engineering
B.S. in chemical engineering

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 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.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Principal Engineer, Pharmaceutical Development
Principal Engineer, Pharmaceutical Development

Nurix Therapeutics • United States

On-site
USD 195,000 - 223,000
Principal Engineer, Pharmaceutical Development
Principal Engineer, Pharmaceutical Development

Nurix Therapeutics • Brisbane (CA)

On-site
USD 195,000 - 223,000
Principal Engineer, Pharmaceutical Development
Principal Engineer, Pharmaceutical Development

NURIX • San Francisco (CA)

On-site
USD 195,000 - 223,000
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

Nurix, Inc. • California (MO), Northern (KY)

Hybrid
USD 188,000 - 209,000
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)
Senior Manager / Associate Director, Regulatory Affairs CMC (Small Molecules)

NURIX • San Francisco (CA)

On-site
USD 188,000 - 209,000
Senior Director, Translational Medicine and Clinical Biomarkers
Senior Director, Translational Medicine and Clinical Biomarkers

Nurix Therapeutics • Brisbane (CA)

On-site
USD 280,000 - 317,000
Senior Director, Translational Medicine and Clinical Biomarkers New Brisbane, California
Senior Director, Translational Medicine and Clinical Biomarkers New Brisbane, California

Nurix, Inc. • California (MO)

Hybrid
USD 280,000 - 317,000
Senior Director, Translational Medicine and Clinical Biomarkers
Senior Director, Translational Medicine and Clinical Biomarkers

NURIX • San Francisco (CA)

On-site
USD 280,000 - 317,000
Associate Director, Regulatory & Medical Writing
Associate Director, Regulatory & Medical Writing

Nurix Therapeutics • Brisbane (CA)

On-site
USD 216,000 - 235,000
Director, Drug Safety
Director, Drug Safety

Nurix Therapeutics • Brisbane (CA)

On-site
USD 247,000 - 317,000