Nurix Therapeutics is a private biopharmaceutical company developing novel small molecule immune modulators for the treatment of cancer and autoimmune diseases. Based on the successful progress of our R&D platform, including expertise in medicinal chemistry, immune cell biology and in vivo pharmacology, Nurix is advancing multiple programs to the clinical stage. The company's lead drugs are a novel protein degradation agent for blood borne tumors and a mechanistically novel oral, immunomodulatory agent for solid tumors.
The candidate will be responsible for chemical development-related activities across the portfolio including process development and manufacture of regulatory starting materials (RSMs) and support production of Drug Substance (DS) for clinical trial materials, and establishment of associated Control Strategy for RSMs and DS to support NDA/MAA filing and commercial manufacturing. The ideal candidate will be a highly motivated leader with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Principal Duties and Responsibilities
- Responsible for supporting RSMs and DS 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 manufacture of RSMs and DS in support of ongoing clinical programs
- Delivery of robust, scalable, and cost-effective phase-appropriate manufacturing and starting material inventory that meet or exceed quality and regulatory requirements
- Support phase-appropriate process characterization, identify critical quality attributes, and implement controls, including selection and justification of 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
- Support 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
- Support 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 edit cGMP batch records, CMC regulatory and Quality documents
- Prepare technical reports, publications, and oral presentations
Skills and Background
- PhD with 5+ years of experience or MS with 10+ years of experience; advanced degree in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline, with 2 years of experience in leadership/management role
- At least 5 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment; experience in CDMO is a plus
- Substantial experience leveraging US and International CRO/CMOs for the manufacture of RSMs and DS to meet aggressive timelines
- Experienced with cGMP manufacturing and IND/IMPD and NDA/MAA filings thorough knowledge of relevant FDA and EMEA regulations
- Experience in supply chain management.
- Able to identify and resolve critical issues
- Experience implementing technical, strategic, and operational plans
- Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
- Qualities of servant leadership and self-awareness required
- Travel up to 50%
Nurix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or genetics. In addition to federal law requirements, Nurix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Nurix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, or veteran status. Improper interference with the ability of Nurix's employees to perform their job duties may result in discipline up to and including discharge.
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