Capricor Therapeutics

Quality Control Scientist, Controls

San Diego, CA

Sponsorship not specified$120k-$140kDetected 61 days ago

ExpressComplianceRecruitingGMPPCRqPCRFlow CytometryMolecular BiologyCell CultureProtein AnalysisLeadershipCommunicationCollaboration

About the role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.
Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
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.

Lead the development, qualification, and maintenance of positive and negative control materials used in QC analytical assays.
Design and execute analytical studies to evaluate assay performance, control suitability, assay robustness, and method reliability.
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.
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.
Strong understanding of assay controls, assay performance monitoring, and analytical method lifecycle management.
Experience with cell therapy, biologics, or exosome-based products.

This listing is sourced directly from Capricor Therapeutics's careers page and normalized into a canonical job model.