Associate Director, Analytical Development and Quality Control - San Francisco - Initial Therapeutics, Inc.

    Initial Therapeutics, Inc.
    Initial Therapeutics, Inc. San Francisco

    1 week ago

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    Description

    Nurix Therapeutics, a clinical stage biopharmaceutical company, focuses on targeted protein degradation medicines for cancer and inflammatory diseases. Our AI-integrated discovery engine leverages ligase expertise to drive clinical advancements.

    Position

    We seek an experienced Associate Director to lead analytical development and quality control. The role involves developing analytical testing methods, identifying technical risks, and collaborating on risk mitigation strategies.

    About the Role

    • 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.
    • Forced degradation, long term stability, and predictive stability studies management.
    • OOS/OOE/OOT investigations contribution.
    • Critical review of data, protocols, reports, specifications, and other documentation.
    • Trending stability data and establishing retest periods/shelf life using statistical methods.
    • Material control strategies and specifications development.
    • Technical documents authorship including test procedures, analytical development reports, product specifications, validation and stability protocols, COAs, stability reports, and storage statements.
    • Relevant IND/IMPD sections authorship.
    • Health authority requests for information responses collaboration.
    • Multidisciplinary teams collaboration including Chemical Development, Formulation Development, Regulatory, Quality, Supply Chain, Medicinal Chemistry, and DMPK.
    • Documentation and data organization management.
    • cGMP quality standards and internal SOPs compliance ensuring.

    Requirements

    • Advanced degree in a relevant discipline (Chemistry, Pharmaceutics, or related field).
    • BS/MS degree with 12+ years or PhD with 6+ years of industrial experience in small molecule pharmaceutical development.
    • HPLC method development expertise essential.
    • Additional experience in techniques such as gas chromatography, NMR, mass spectrometry, particle size analysis, solid state characterization, dissolution, ICP-MS/OES, and/or FTIR.
    • Solid understanding of phase-appropriate approaches to control strategy, method validation, and retest/expiry.
    • Analytical development and validation for drug substances, starting materials, synthetic intermediates, and solid oral drug products experience.
    • CDMO/CROs analytical activities management experience.
    • Stability programs, reference standards, and retest/expiry management experience.
    • ICH guidelines, cGMPs, and pharmacopeial chapters familiarity.
    • OOS/OOE/OOT management, deviation management, and change control experience.
    • Data interpretation and technical concept articulation ability.
    • Project timelines satisfaction ensuring assigned activities completion ability.
    • Strong interpersonal skills fostering collaboration within and outside the organization.

    Fits with Nurix Culture and Values

    • Strong team orientation; highly collaborative.
    • Solutions and results-oriented focus.
    • Hands-on approach; resourceful and open to diverse points of view.
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