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Capricor Therapeutics

Posted 1 month ago

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Quality Control Scientist, Controls

San DiegoOn-siteFull-time

AI Summary

Leads development, qualification, and lifecycle management of analytical control materials for QC assays, designs studies, troubleshoots methods, and ensures regulatory-compliant analytical readiness.

About this role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Quality Control Scientist, Controls will lead the development, qualification, and lifecycle management of analytical control materials used in QC assays. This role will be responsible for generating and maintaining positive and negative controls, designing and executing analytical studies, and troubleshooting and optimizing analytical methods used in QC testing.
This position plays a critical role in ensuring assay reliability, reproducibility, and regulatory compliance within the QC laboratory. The individual will provide scientific leadership for assay control strategies, oversee analytical lifecycle activities for control materials, and collaborate with Quality Control, Analytical Development, Process Development, Manufacturing, and Quality teams to ensure robust analytical readiness across Capricor’s therapeutic programs.

Responsibilities

  • Lead the development, qualification, and maintenance of positive and negative control materials used in QC analytical assays.
  • Establish and oversee assay control strategies to ensure reliable assay performance and consistency across QC testing programs.
  • Serve as the scientific owner for control materials within the analytical lifecycle framework, including control generation, qualification, monitoring, and lifecycle management.
  • Design and execute analytical studies to evaluate assay performance, control suitability, assay robustness, and method reliability.
  • Provide scientific leadership for assay troubleshooting and optimization activities to improve assay robustness and reproducibility.
  • Evaluate assay performance trends and control performance data to identify opportunities for improving assay reliability.
  • Analyze experimental data, interpret results, and generate scientific reports, study summaries, and technical documentation.
  • Document experimental work and study outcomes in accordance with GMP and data integrity requirements.
  • Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, control qualification records, and analytical lifecycle documentation.
  • Support regulatory inspection readiness by ensuring analytical control strategies, documentation, and study records meet regulatory expectations.
  • Provide scientific support for investigations including deviations, OOS/OOT events, and assay performance issues.
  • Collaborate with Analytical Development, Process Development, Manufacturing, and Quality teams to support assay lifecycle management and continuous improvement initiatives.
  • Manage multiple scientific projects and timelines to support QC laboratory priorities.
  • Perform additional QC duties as assigned.

    • Required Qualifications (Must‑Haves)

  • Ph.D. in Biological Sciences, Biochemistry, Molecular Biology, Bioengineering, or a related discipline.
  • Strong background in primary cell culture and analytical assay development, troubleshooting, and experimental design.
  • Hands-on experience with analytical techniques such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell-based assays.
  • Experience designing and executing analytical studies and interpreting experimental data.
  • Strong understanding of assay controls, assay performance monitoring, and analytical method lifecycle management.
  • Strong written and verbal communication skills with the ability to clearly summarize complex scientific findings.
  • Ability to work independently and manage multiple scientific projects in a fast-paced environment.

    • Preferred Qualifications (Nice‑to‑Haves)

  • Experience working in GMP or regulated laboratory environments.
  • Experience supporting analytical method qualification, validation, or lifecycle management.
  • Experience working with cell-based assays or mammalian cell culture systems.
  • Experience supporting deviations, assay investigations, or technical reports in regulated environments.
  • Experience with cell therapy, biologics, or exosome-based products.

    • Work Environment & Physical Requirements

  • Laboratory-based role requiring routine bench work.
  • Work involves analytical instrumentation, laboratory documentation, and computer-based data analysis.
  • Ability to lift up to 20 pounds.
  • Occasional participation in cross-functional meetings and technical discussions.

    • Skills

    Analytical Assay DevelopmentAnalytical Lifecycle ManagementAssay QualificationControls Generation And QualificationData IntegrityELISAFlow CytometryGMP DocumentationMethod ValidationOOS/OOT InvestigationsPCRPositive And Negative ControlsQPCRSOP UpdatesStatistical AnalysisStudy DesignTechnical Reports

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