Job Description
Job DescriptionAbout Capricor Therapeutics
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our innovative platforms, including our lead product, deramiocel (CAP-1002), and our proprietary StealthX™ platform, to engineer cutting-edge treatments. Our team is committed to harnessing advanced science and technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.
About the Role
The Quality Control Associate I/II will play an essential role in supporting Capricor’s commitment to delivering high-quality therapies by ensuring the integrity of raw materials and analytical processes at our San Diego facility. This position involves hands-on quality control testing, coordination with external laboratories, and collaboration with development teams to optimize and develop assays. The associate will contribute to GMP compliance, support the release of critical materials, and drive operational excellence in a dynamic, collaborative environment. This role is ideal for a motivated individual eager to grow their expertise in quality control while making a tangible impact on the development of transformative therapies for rare diseases.
Responsibilities
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Conduct raw material inspections, including verification of Certificates of Analysis (CoAs), label checks, and documentation review per internal procedures and compendial standards.
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Perform quality control testing of raw materials to support GMP release and regulatory compliance.
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Coordinate with outsourced laboratories for sample receipt, testing, and timely reporting of results.
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Analyze data and maintain organized records, reports, and databases.
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Write technical reports, deviations, and OOS investigation documentation.
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Collaborate with Process/Analytical Development to troubleshoot and optimize assays and develop new analytical methods.
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Train employees on relevant techniques and procedures.
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Write or revise quality control SOPs and Material Specifications.
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Coordinate with third-party vendors to maintain equipment calibration.
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Work with Supply Chain and Quality Assurance to resolve raw material receipt and testing issues.
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Present data internally to support project goals.
Requirements
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Bachelor’s degree in a relevant Biological Science discipline.
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2+ years of experience in a GMP Quality Control laboratory or GMP/GLP setting (preferred).
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Experience with laboratory methods including endotoxin detection and FTIR.
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Familiarity with method qualification/validation (preferred).
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Ability to independently perform laboratory analysis, troubleshoot, and improve methods.
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Demonstrated history of successful, independent laboratory work.
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Excellent communication, time-management, and teamwork skills.
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Proficiency with Outlook, MS Office, and other electronic systems.
Work Environment / Physical Demands
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Must be able to sit or stand for extended periods, move around the facility, communicate effectively, and lift/carry up to 40 lbs.
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Ability to gown and work in a classified area as required.
Compensation (USD)
This role offers a competitive salary based on experience and qualifications. Additional benefits include health/dental/vision insurance, paid time off, parental leave, 401k retirement plan, company stock options, and bonus eligibility.
Location Policy
This position is based at our headquarters in San Diego, California.
Come Work With Us!
Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry and making a real impact on patients’ lives, we’d love to hear from you!