Associate Director, Chemical Development

Initial Therapeutics, Inc.; Brisbane (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 and DS/RSM program execution. You will oversee CMOs, drive process development, and ensure regulatory submissions meet ICH and FDA requirements.

The role requires a PhD in a related field and 5+ years in pharma/biotech CMC/cGMP, with experience in scale-up, QbD, and IND/NDAs. Up to 50% travel may be required.

Qualifications

• PhD in a related field plus 5 years of industry experience in a pharmaceutical/biotechnology CMC/cGMP environment.
• Development of safe, scalable, phase-appropriate routes of synthesis to drug substance targets.
• Oversight of US and international CMOs for cGMP manufacture of drug substances.
• Authoring Module 3 sections for IND/IMPD and/or NDA/MAA filings; familiarity with ICH Q7 and FDA/EU GMP guidelines.

Responsibilities

• Responsible for regulatory starting materials (RSMs) and Drug Substance cGMP manufacturing activities, including scale-up to support candidate selection.
• Identify, select, and manage CMOs for process optimization and cGMP manufacture of DS for clinical programs.
• Deliver robust, scalable manufacturing of DS meeting quality and regulatory requirements; implement process characterization and DS Control Strategy.

Education

PhD in Chemical Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related field

Job description

*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.