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Bioagilytix

Posted 14 days ago

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Associate Director, Operations - GMP

DurhamOn-site

AI Summary

Leads GMP laboratory operations at a bioanalytical lab, overseeing lot release and stability testing for biologics, gene therapies, and cell therapies while managing managers and ensuring scientific quality and delivery.

About this role

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

BioAgilytix is seeking an Associate Director to lead GMP laboratory operations at our Raleigh-Durham facility, supporting lot release and stability testing for biologics, gene therapies, cell therapies, and related products. This role leads multiple teams through managers and supervisors and is accountable for scientific quality, operational performance, capacity, and reliable delivery.

The Associate Director will provide technical and operational direction across multiple analytical platforms and support clients and internal scientific teams. The ideal candidate will bring strong GMP laboratory experience, particularly with lot release and stability testing, along with experience supporting external clients or internal stakeholders.

Success in this role requires strong relationship-building skills, sound judgment, and the ability to lead effectively through change. The Associate Director will take ownership of complex projects, establish a clear path forward when information is incomplete, and work independently while engaging the appropriate partners at key decision points.

Essential Responsibilities:

  • Lead managers, supervisors, and scientific teams responsible for GMP laboratory operations, with accountability for performance, quality, capacity, and delivery.
  • Oversee GMP sample analysis supporting lot release, stability, characterization, and other specification-driven testing.
  • Provide technical and operational oversight for validated and transferred analytical methods throughout the method lifecycle.
  • Evaluate assay performance and lead the resolution of complex scientific and operational issues.
  • Lead or oversee laboratory investigations involving deviations, out-of-specification and out-of-trend results, CAPAs, change controls, root-cause analysis, and effectiveness monitoring.
  • Review and approve GMP laboratory documentation, which may include raw data, analytical data packages, test methods, protocols, reports, certificates of analysis, and investigation records.
  • Establish and monitor laboratory, operational, and assay-performance metrics. Identify adverse trends and implement sustainable corrective or preventive actions.
  • Monitor capacity, throughput, utilization, and backlog and take action to improve performance and delivery.
  • Standardize workflows, management routines, metrics, and escalation processes across the assigned area.
  • Resolve cross-functional issues affecting staffing, quality, timelines, and client commitments.
  • Build effective relationships with clients and internal partners across Operations, Quality Assurance, scientific functions, and other business teams.
  • Support client audits, regulatory inspections, and the preparation of technical responses.
  • Develop managers and supervisors, strengthen leadership capability, and support succession planning across the organization.
  • Contribute to budget planning, headcount planning, audit readiness, and process-improvement initiatives.
  • Translate departmental goals into operating plans and communicate progress, risks, and mitigation actions to leadership.
  • Perform other duties as assigned.

    • Minimum Preferred Qualifications: Education/Experience

  • Bachelor’s degree in scientific discipline, life sciences, operations, quality, or a related field.
  • Eight (8) or more years working in a regulated laboratory, pharmaceutical, biotechnology, CDMO, CRO, bioanalytical, quality, or scientific operations environment.
  • Six (6) or more years of people leadership.
  • Technical and operational leadership of GMP sample analysis supporting lot-release, stability, characterization, or other specification-driven testing.
  • Client support or internal scientific stakeholder management within a regulated environment.
  • An equivalent combination of directly relevant education, training, and experience may be considered.

    • Minimum Preferred Qualifications: Skills

  • Extensive knowledge of GMP laboratory controls, data-integrity expectations, analytical method lifecycle management, and the execution of validated or transferred methods.
  • Technical knowledge of multiple analytical platforms used to test biologics, gene therapies, cell therapies, or related products, which may include:
    • Cell-based potency and functional assays
    • ELISA and other ligand-binding or immunoassay platforms
    • qPCR and ddPCR
    • Plate-based fluorescence, luminescence, or absorbance assays
    • Flow cytometry
    • HPLC or UHPLC
    • Capillary electrophoresis
    • General protein and molecular-biology techniques
    • Ability to evaluate assay performance, troubleshoot complex scientific and operational issues, and make well-supported decisions.
    • Strong working knowledge of laboratory investigations and quality processes, including deviations, CAPAs, change controls, root-cause analysis, and effectiveness monitoring.
    • Ability to review and approve GMP laboratory documentation, including raw data, analytical data packages, test methods, protocols, reports, certificates of analysis, and investigation records.
    • Ability to establish and monitor laboratory and assay-performance metrics, identify adverse trends, and implement sustainable corrective or preventive actions.
    • Sound judgment and the ability to lead through changing priorities.
    • Strong relationship-building skills and the ability to work effectively across Operations, Quality Assurance, scientific teams, clients, and company leadership.
    • Clear written and verbal communication skills, including the ability to explain complex scientific, quality, and operational information during technical discussions, audits, and leadership presentations.

    • Preferred Credentials

  • Advanced degree preferred

    • Supervisory Responsibility:

  • Directly supervises managers and/or supervisors and is accountable for organizational structure, talent development, succession planning, and team performance across multiple groups.

    • Supervision Received:

  • Works under limited supervision of the Director, Operations.
  • Exercises significant discretionary authority in prioritization, cross-functional coordination, and operational improvement decisions.

    • Position Type and Expected Hours of Work:

  • This is a full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and evening work required

    • Skills

    Absorbance AssaysAnalytical Method Lifecycle ManagementBacklog ManagementCapacity PlanningCAPAsCapillary ElectrophoresisCell-based Potency AssaysChange ControlsData IntegrityDdPCRDeviationsEffectiveness MonitoringELISAFlow CytometryFunctional AssaysGMP Laboratory ControlsHPLCImmunoassay PlatformsLaboratory InvestigationsLaboratory MetricsLigand-binding AssaysLot Release TestingLuminescenceMolecular Biology TechniquesPlate-based FluorescenceProtein TechniquesQPCRRoot-cause AnalysisStability TestingThroughputTransferred MethodsUHPLCUtilizationValidated Methods

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