What are the responsibilities and job description for the Associate Director, Chemical Development position at Nurix Therapeutics?
Nurix Therapeutics (www.nurixtx.com) is a public 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 active pharmaceutical ingredients (APIs) to support production of clinical trial materials, process characterization and establishment of associated Control Strategy 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 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 and DS inventory that meet or exceed 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
Skills and Background
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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