What are the responsibilities and job description for the Associate Director, Analytical Development and Quality Control position at Initial Therapeutics, Inc.?
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Position
Nurix Therapeutics seeks an experienced Associate Director to join the Analytical Development and Quality Control group to lead IND-enabling and early phase analytical development. The Associate Director will develop analytical testing and characterization methods to evaluate drug substance and drug product attributes, identify and characterize technical risk, and collaborate toward risk mitigation strategies. The Associate Director will oversee and execute analytical development, validation, and testing operations both internally and at external CDMO / CRO partners and author relevant sections of regulatory filings.
This position is based at Nurix headquarters in San Francisco, CA.
Key responsibilities include :
- Chemical and physical characterization of drug substance and drug product attributes, identification of technical risks, and collaboration on risk mitigation strategy.
- Method development for and analytical characterization of drug substances, drug products, and product stability.
- Management of method development, method validation, QC testing, and reference standard management activities internally and at CDMOs / CTLs.
- Management of forced degradation, long term stability, and predictive stability studies.
- Contribution to OOS / OOE / OOT investigations.
- Critical review of data, protocols, reports, specifications, and other documentation.
- Trending stability data and establishing retest periods / shelf life using statistical methods.
- Collaboration in the development of material control strategies and specifications.
- Authorship of technical documents including test procedures, analytical development reports, product specifications, validation and stability protocols, COAs, stability reports, and storage statements.
- Authorship of relevant IND / IMPD sections.
- Collaboration toward responses to health authority requests for information.
- Collaboration in multidisciplinary teams that include Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK.
- Management and organization of documentation and data.
- Ensuring compliance to cGMP quality standards and internal SOPs.
- Travel up to 15%.
Required Qualifications
Fit with Nurix Culture and Values
Application Process
Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Note to Employment Agencies : Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.
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 ( https : / / www.nurixtx.com / privacy-policy / ).
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