Senior Manager/Associate Director, Analytical Development and Quality Control
3 days ago
Nurix Therapeutics is a biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative small molecule therapies for cancer and immune disorders.
We are seeking an experienced Senior Manager/Associate Director to join our CMC Analytical Development and Quality Control team. The successful candidate will oversee and execute analytical development, tech transfer, and testing operations, evaluate and implement new analytical and data management technologies, and author relevant sections of regulatory filings.
Key Responsibilities:- Manage key activities at CDMO/CTLs, including method development, validation/tech transfer, QC testing, and reference standard management.
- Execute in-house analytical laboratory activities, including method development/troubleshooting and material characterization.
- Analytical characterization of drug substance and drug product, impurities, and product stability.
- Manage OOS/OOE/OOT investigations, deviations, and associated documentation.
- Critical review of data, protocols, reports, specifications, and other CDMO/CTL documents.
- Collaborative development of product control strategy and specifications.
- Authorship of technical documents, including specifications, protocols, COAs, test procedures, development reports, stability reports, and storage statements.
- Authorship of relevant IND/IMPD and NDA/MAA sections.
- Trending stability data and establishing retest periods and shelf life using statistical methods.
- Collaboration in multidisciplinary teams, including Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK.
- Supporting supplier qualification, site visits, and audits.
- Management and organization of documentation and data.
- Ensuring compliance to cGMP quality standards and internal SOPs.
- Travel up to 20%.
- Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
- Senior Manager: BS degree with 8+ years, MS degree with 6+ years, or PhD with 4+ years of relevant industrial experience in small molecule pharmaceutical analytical development.
- Associate Director: BS/MS degree with 12+ years, or PhD with 8+ years of relevant industrial experience in small molecule pharmaceutical analytical development.
Nurix Therapeutics offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
We are an equal opportunity employer and welcome applications from diverse candidates.
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