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Posted 14 hours ago
Manager, Analytical Development and Quality Control
Nurix TherapeuticsManager, Analytical Development and Quality Control
Requirements
MS in Chemistry or related field with 8-10+ years experience, PhD in similar discipline with 5-8+ years experience, Expertise in analytical method development and validation, Experience with ICH guidelines, Knowledge of HPLC, GC, ICP-MS, and XRPD, Experience with regulatory submissions (IND, NDA), Experience managing CDMOs
Skills
HPLCAnalytical Chemistry
About the role
Responsibilities
- Provide strategic and technical leadership for analytical CMC activities across multiple programs
- Lead technology transfer and knowledge management to internal teams and external stakeholders
- Ensure analytical method development, validation, and lifecycle management align with ICH guidelines
- Establish and communicate analytical control strategies across cross-functional teams
- Drive robust knowledge management through high-quality technical writing and data governance
- Oversee external partners and CDMOs to manage outsourced analytical activities
Requirements
- MS in Chemistry, Analytical Chemistry, or related field with 8–10+ years of experience, or PhD with 5–8+ years of experience
- Demonstrated leadership in managing analytical CMC activities
- Expertise in analytical method development, validation, and transfer per ICH guidelines
- Proficiency with analytical techniques such as HPLC/UPLC, GC, KF, ICP-MS, IC, XRPD, and PSD
- Experience authoring and reviewing regulatory submissions (INDs, IMPDs, NDAs)
- Proven track record supporting NDA submissions and interacting with regulatory agencies
- Strong technical writing skills for validation, transfer, and investigation reports
- Experience managing CDMOs and external analytical partners
About the Company
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines for cancer and inflammatory diseases.
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Get started — it's freeManager, Analytical Development and Quality Control
Nurix Therapeutics · Brisbane
