Nurix Therapeutics
Director, Pharmaceutical Development
Brisbane, CA · Director
Sponsorship not specified$218k-$260kDetected 3 days ago
C++Project ManagementSupply ChainPatient CareGMPFDA RegulatoryLeadershipCommunicationCollaborationMentoringRegulatory Affairs
About the role
- 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 Nurix Therapeutics, Inc. is seeking a highly experienced Director of Pharmaceutical Development.
- span QbD-based formulation and process development from early phase through commercial launch.
Responsibilities
- Lead QbD-based formulation and process development for small molecule drug programs with a focus on oral and topical dosage forms across all development phases.
- Define and document the Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs) to guide formulation strategy.
- Develop and optimize manufacturing processes appropriate to the dosage form, ensuring scalability and process robustness.
- Lead manufacturing scale-up activities from laboratory to pilot and commercial scale, ensuring robust and reproducible processes.
- drive root cause analysis and implement corrective actions.
- Drive late-stage development activities (Phase 2b through commercial launch) including clinical supply manufacturing, process performance qualification (PPQ), and continued process verification (CPV).
- Troubleshoot manufacturing deviations, out-of-specification results, and process failures; drive root cause analysis and implement corrective actions.
- Manage external CDMO partnerships, including vendor qualification, technical oversight, and performance governance to ensure project timelines, quality standards, and budget commitments are met.
- 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.
- The role leads small molecule drug product development focused on oral and topical dosage forms.
Requirements
- 12+ years of progressive pharmaceutical development experience in an industry setting (biotechnology, pharmaceutical, or CDMO).
- Comprehensive hands-on experience with QbD methodologies: QTPP definition, CQA identification, CMA/CPP risk assessment, DoE, design space development, and control strategy establishment.
- Significant late-stage development experience (Phase 2b/3 and NDA/MAA submission) is required.
- Proven track record of authoring and/or reviewing CMC regulatory submissions (INDs, NDAs, CTDs) and successfully responding to agency queries.
- Knowledge of lifecycle management, post-approval changes, and SUPAC guidance.
- occasional GMP manufacturing facility access required.
- Approximately 25% travel required, including domestic and international trips to CDMO sites, clinical manufacturing sites, regulatory agency meetings, and scientific conferences.
- Must be able to gown for cleanroom/GMP environments
Nice to have
- Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline strongly preferred with 12 years of industry experience.
Compensation
- Salary Range: 218K – 260K plus bonus and equity.
Benefits
- 218K - 260K plus bonus and equity.
- Equal Opportunity Employer offering a competitive salary and benefits package.
Equal opportunity
- Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
- Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package.
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