Summary:
Nurix Therapeutics (www.nurixtx.com) is a private biopharmaceutical company developing novel small molecule immune modulators, large molecules, and other modalities 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 build and lead a group responsible for analytical development & Quality Control-related activities across the portfolio including method development, from early analytical methods to support research, process development and manufacture of active pharmaceutical ingredients (APIs) and drug products to support production of clinical trial materials, characterization of process characterization and to establishment of associated Control Strategy to support NDA 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

• Provide overall responsibility for all Analytical Development & QC (ADQC) related activities, including method development of candidate compounds to support candidate selection during drug discovery, from preclinical development through commercialization
• Provide overall strategic management, direction, and motivation of physical, chemical, biopharmaceutic and analytical testing professionals that are responsible for the advancement of R&D and commercial programs
• Determine and supports new areas of analytical science and related technologies for potential use in new methods
• Identification, selection, and management of Contract Research Organizations (CROs) for method development and optimization, method qualification of test methods to support manufacturing and release of regulatory starting materials, intermediates, APIs, drug product intermediates, bulk, and finished products to support ongoing clinical and commercial programs
• Provide leadership and expertise in physical/chemical, biopharmaceutical, biological and parenteral testing for the discovery and development of small and large molecules and other modalities and delivery mechanisms, which includes managing the resources and analytical strategies for development and testing a portfolio of development candidates across many modalities
• Ensure that analytical methods are properly qualified and validated appropriate for the phase of development, the analytical data that the methods generated are scientifically sound, reliable, and compliant with regulatory authorities, and that the methods are ultimately transferable to commercial organizations around the world
• Implement phase-appropriate test methods, controls, specifications, and stability programs, and support the selection and justification of specifications for regulatory starting materials (RSMs), GMP intermediates, APIs, and drug products to ensure that all CROs and CMOs are using systems and methods in compliance with all relevant regulatory standards to ensure consistency of product 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 Control Strategies to support NDAs/MAAs
• Develop and execute plans for the primary stability registration and validation batches of APIs and DPs as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
• Lead analytical validation programs to support clinical development and commercialization
• Provide GMP and GLP reliable testing methods and analytical testing data, and prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the analytical 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 or MS with 15 years of experience; advanced degree in Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
• Substantial experience leveraging US and International CRO/CMOs for the release testing of RSMs, APIs and DPs to meet accelerated timelines
• Substantial experience with projects in clinical development (e.g., Phase 1 through Phase 3 including multiple pharmaceutical dosage forms such as tablets, capsules, topicals, etc.) and commercial manufacturing
• Experienced with cGMP manufacturing and IND, CTA, and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
• Experience in development of chemistry, manufacturing, and controls.
• 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

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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