layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Director, Pharmaceutical Development at Nurix Therapeutics | LAYIQ

Formulation & Process Development
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.
Apply expertise in BCS Class II/IV compound development and enabling formulation technologies, including amorphous solid dispersions (spray-dried dispersions, hot-melt extrusion), lipid-based drug delivery systems (SMEDDS, SEDDS, lipid suspensions), and nano-formulations to address solubility and bioavailability challenges.
Define and document the Quality Target Product Profile (QTPP) and identify Critical Quality Attributes (CQAs) to guide formulation strategy.
Conduct systematic risk assessments to identify Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) using FMEA and other risk assessment tools.
Develop and optimize manufacturing processes appropriate to the dosage form, ensuring scalability and process robustness.
Scale-Up & Technology Transfer
Lead manufacturing scale-up activities from laboratory to pilot and commercial scale, ensuring robust and reproducible processes.
Troubleshoot manufacturing deviations, out-of-specification results, and process failures; drive root cause analysis and implement corrective actions.
Late-Stage Development & Regulatory
Drive late-stage development activities (Phase 2b through commercial launch) including clinical supply manufacturing, process performance qualification (PPQ), and continued process verification (CPV).
Author and review CMC sections of regulatory submissions including INDs, NDAs, and MAAs.
Ensure all development activities comply with current GMP regulations and internal quality standards.
CDMO Management & Cross-Functional Leadership
Manage external CDMO partnerships, including vendor qualification, technical oversight, and performance governance to ensure project timelines, quality standards, and budget commitments are met.
Serve as the primary technical point of contact between pharmaceutical development and cross-functional teams including Analytical Development, Clinical Operations, Regulatory Affairs, Quality, Supply Chain, and Commercial.
Provide scientific leadership and mentorship to junior scientists, associates, and project team members.

Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Chemistry, or a closely related discipline strongly preferred with 12 years of industry experience.
12+ years of progressive pharmaceutical development experience in an industry setting (biotechnology, pharmaceutical, or CDMO).
Deep expertise in small molecule drug product development with a focus on oral and topical dosage forms, especially enabled formulation development (e.g., amorphous solid dispersions, lipid-based systems, nano-formulations).
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.
Direct CDMO management experience, including technical oversight, project governance, and relationship management.
Knowledge of lifecycle management, post-approval changes, and SUPAC guidance.
For the Director level: demonstrated people management experience leading a team of scientists/managers, department-level strategic planning, and budget/resource ownership across multiple concurrent programs.
Primarily office and laboratory environment; 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
Core Competencies
Scientific Leadership — Recognized internal and external thought leader in pharmaceutical development; drives scientific innovation and excellence.
Strategic Thinking — Ability to anticipate technical and regulatory risks and develop proactive mitigation strategies that protect project timelines.
Cross-Functional Collaboration — Demonstrated ability to build strong working relationships and influence without authority across diverse internal and external stakeholders.
Project Management — Experienced in managing multiple complex projects simultaneously in a fast-paced, deadline-driven environment.
Communication — Exceptional written and verbal communication skills; able to present complex scientific data clearly to both technical and non-technical audiences, including senior leadership and regulatory agencies.
People Development — Commitment to mentoring and developing scientific talent within the organization.

Director, Pharmaceutical Development

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