Associate Director, Chemical Development

NURIX; San Francisco (CA); On-site; USD 243,000 - 257,000; Full time

Job summary

Nurix Therapeutics, Inc. in Brisbane, CA is seeking an Associate Director, Chemical Development to lead cGMP manufacturing for drug substances and coordinate with CMOs for scalable production.

The role supports early to late-stage programs, ensuring quality and regulatory compliance across DS manufacturing and related CMC activities. The position requires a PhD in a related field and at least five years of industry experience, with readiness to travel up to 50%.

Qualifications

• PhD in a relevant scientific discipline plus 5 years in pharma/biotech CMC/cGMP.
• Experience leading CMOs for cGMP drug substance manufacture.
• Experience with IND/NDA/MAA filings and ICH/FDA guidelines.

Responsibilities

• Oversee regulatory starting materials (RSMs) and Drug Substance (DS) cGMP manufacturing.
• Manage CMOs for DS manufacturing and process optimization.
• Lead QS/QbD initiatives to establish DS control strategy for NDAs/MAAs.
• Prepare CMC sections for regulatory filings and support INDs/NDAs.

Skills

cGMP manufacturing

CMO oversight

Regulatory submissions

Process characterization

DOE

QbD

Education

PhD in Chemical Engineering/Pharmaceutical Science

Job description

Associate Director, Chemical Development

Brisbane, California, United States

*DNP* *CBD*

Nurix Therapeutics, Inc. has job openings (multiple) for the position of Associate Director, Chemical Development based out of its location in Brisbane, CA. The offered wage is: $243,410.16 to $256,800 per year. The base salary for this position is $243,410.16, higher compensation may be available with advanced skills and/or experience.

Job Duties: 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. Up to 50% domestic and foreign travel is required. Percentage of foreign and domestic travel can vary by project needs.

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

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