Associate Director Chemical Development
Associate Director Chemical Development
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Salary Not Disclosed
1 Vacancy
Job Description
Nurix Therapeutics () 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 companys lead 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 developmentrelated 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 scaleup 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 costeffective phaseappropriate manufacturing and DS inventory that meet or exceed quality and regulatory requirements
Implement phaseappropriate 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
PhD or MS with 12 years of experience; advanced degree in Chemical Engineering Pharmaceutical Chemistry Organic Chemistry Pharmaceutics Pharmaceutical Science or related scientific discipline with 4 years of management experience
At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
Substantial experience leveraging US and International CRO/CMOs for the manufacture of cGMP DS to meet aggressive timelines
Substantial experience with projects in latestage development
Substantial 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
Work well in a collaborative environment with analytical formulation quality and regulatory teams
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 selfawareness 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 Nurixs employees to perform their job duties may result in discipline up to and including discharge.
Nurix Therapeutics Inc. is committed to protecting and respecting your privacy and personal information including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix you agree to our collection and use of personal information as described in our Privacy Policy Experience:
Director
Employment Type
Full Time
Key Skills
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