Associate Director, Chemical Development

Nurix•Brisbane, CA

8d•$243,410 - $256,800•Onsite

About The Position

Nurix Therapeutics, Inc. is seeking an Associate Director, Chemical Development to be responsible for regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing related activities. This includes scaling up candidate compounds to support drug discovery candidate selection, from preclinical development through commercialization. The role involves identifying, selecting, and managing Contract Manufacturing Organizations (CMOs) for process optimization and cGMP manufacture of DS for clinical programs. The Associate Director will ensure the delivery of robust, scalable, and cost-effective phase-appropriate manufacturing of DS that meets quality and regulatory requirements. Key responsibilities include implementing phase-appropriate process characterization, identifying critical quality attributes, and implementing controls, including the selection and justification of regulatory starting materials (RSMs). This ensures CROs and CMOs comply with regulatory standards and maintain DS quality consistency. The role also involves leading the characterization of late-phase programs using QbD principles, identifying critical quality attributes and process parameters, and implementing a DS Control Strategy for NDAs/MAAs. Support for RSMs and DS supply chain and logistics is also required. The position entails developing and executing plans for primary stability registration and validation batches of DS according to cGMP, ICH, and FDA regulations, and leading process validation programs for commercialization. The Associate Director will prepare and review CMC sections of regulatory submissions and represent the company as the DS expert to regulatory authorities. Preparation, review, and approval of cGMP batch records, CMC regulatory and Quality documents, and technical reports, publications, and presentations are also part of the role. Up to 50% domestic and foreign travel may be required.

Requirements

Doctorate (PhD) in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
5 years of industry experience in a pharmaceutical or biotechnology CMC/cGMP environment
Demonstrated experience with development of safe, scalable, phase-appropriate routes of synthesis to drug substance targets
Demonstrated experience with oversight of US and international contract manufacturing organizations for the manufacture of cGMP new chemical entity drug substances
Demonstrated experience with authoring Module 3 Sections for IND/IMPD and/or NDA/MAA filings
Demonstrated experience with ICH Q7, FDA 21 CFR Part 210, 211 and EU GMP Volume 4 Part I and II guidelines

Responsibilities

Responsible for regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing related activities, including scale-up of candidate compounds to support candidate selection during drug discovery, from preclinical development through commercialization.
Identification, selection, and management of Contract Manufacturing Organizations (CMOs) for process optimization and cGMP manufacture of DS in support of ongoing clinical programs.
Delivery of robust, scalable, and cost-effective phase-appropriate manufacturing of DS that meets or exceeds quality and regulatory requirements.
Implement phase-appropriate process characterization, identify critical quality attributes, and implement controls, including selection and justification of regulatory starting materials (RSMs) to ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards and to ensure consistency of DS quality.
Lead the characterization of late phase programs according to the principles of QbD (mapping studies, DOEs) to identify critical quality attributes and critical process parameters (including edge of failure and proven acceptable ranges) and implement DS Control Strategy to support NDAs/MAAs.
Support management of RSMs and DS supply chain and logistics in support of demand for clinical studies and commercial products.
Develop and execute plans for the primary stability registration and validation batches of DS as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
Lead process validation programs to support commercialization.
Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the DS expert before U.S. and European regulatory authorities.
Prepare, review, or approve cGMP batch records, CMC regulatory and Quality documents.
Prepare technical reports, publications, and oral presentations.