Associate Director, Quality Control - San Francisco - Senti Biosciences

    Senti Biosciences
    Senti Biosciences San Francisco

    1 week ago

    Default job background
    Description

    Sentibiosciences is seeking an Associate Director of Quality Control to serve as the primary point of contact and Subject Matter Expert for all QC topics.

    This role will involve establishing phase-appropriate QC programs, representing QC and Sentibiosciences Quality in internal and external activities, overseeing outsourced product release and stability testing, managing data generated by contract test labs, leading stability programs, collaborating with internal and external teams, and supporting lot disposition activities.

    The ideal candidate brings broad QC experience in early- and late-phase clinical environments, Cell Therapy experience, excellent communication skills, a collaborative mindset, and an agile hands-on approach.

    Responsibilities

    • Establish QC Programs: Develop phase-appropriate QC programs, ensuring alignment with regulatory expectations.
    • Represent QC and Sentibiosciences Quality: Represent QC and Sentibiosciences Quality in internal and external activities.
    • Oversee Outsourced Testing: Oversee outsourced product release and stability testing, manage data generated by contract test labs.
    • Lead Stability Programs: Lead stability programs including driving stability strategy, writing protocols, reports, data management, and trending.
    • Collaborate with Internal and External Teams: Collaborate effectively with internal Analytical Development team and external manufacturing partners and Contract Test Labs (CTLs) to support testing, troubleshooting, method transfer, method qualification, and investigations of Out-of-Trend/Out-of-Specification (OOT/OOS), deviations.
    • Lead Method Validation Strategy: Lead method validation strategy and support Contract Development and Manufacturing Organizations (CDMOs) through method validation execution and reporting.
    • Support Lot Disposition Activities: Support lot disposition activities as needed, including test record review, review of QC-relevant investigations, etc.
    • Participate in Product Specifications: Participate in setting and revision of product specifications.
    • Author IND-associated Documentation: Author and review IND-associated documentation including technical source documents.
    • Maintain QC Data Systems: Establish and maintain systems for QC data archiving and retention.
    • Present QC Metrics: Present QC metrics and data trend analysis to Quality Management Review.

    Qualifications

    • Bachelor's Degree: Bachelor's degree in life science or related discipline.
    • Quality Control Experience: At least 8+ years of Quality Control experience in biologic therapeutics including products in clinical development.
    • Method Transfer Experience: Method transfer, qualification, and validation experience.
    • Cell/Gene Therapy Experience: Experience with early clinical stage cell/gene therapy programs preferred.
    • Excellent Communication Skills: Excellent verbal and written communication skills.
    • Risk-based Approach: Employ a risk-based and data driven approach to compliance.
    • Strong Interpersonal Skills: Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel.
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