Quality Control Associate II/III, Analytical

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 Associate II/III, Analytical will perform analytical testing to support batch disposition, in process control, drug substance and drug product release, and stability studies. This role is central to ensuring product quality and regulatory compliance for Capricor’s cell based and exosome based therapeutic platforms.

You will execute analytical assays, maintain mammalian cell cultures, document data in GMP compliant systems, support investigations, and collaborate cross functionally to ensure testing readiness and continuous improvement. This is a hands-on QC bench role within an expanding analytical team and a new headcount supporting pipeline and manufacturing scaleup.

Responsibilities:
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Perform QC analytical testing on in process materials, bulk drug substances, and final products to support batch release and stability programs.

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Maintain and prepare mammalian cell cultures used in potency or characterization assays.

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Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA based methods.

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Analyze data, generate results, and enter findings into QC systems and reports.

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Document all work in accordance with GMP and data integrity standards, including batch records, lab notebooks, and controlled forms.

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Communicate test results, issues, or atypical findings to QC leadership and development partners.

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Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates.

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Assist with assay troubleshooting in collaboration with Process and Analytical Development.

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Train team members on relevant lab techniques or QC procedures.

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Support updates to QC SOPs and continuous improvement initiatives.

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Manage testing priorities to meet project timelines and operational needs.

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Perform additional QC duties as assigned.

Required Qualifications (Must‑Haves):
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Bachelor’s degree in Biological Sciences or related field.

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2+ years of experience in a GMP QC laboratory or GMP/GLP environment.

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Handson experience with mammalian cell culture.

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Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies.

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Strong GMP documentation, data integrity, and compliant data recording skills.

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Ability to work independently, manage multiple testing assignments, and meet tight timelines.

Preferred Qualifications (Nice‑to‑Haves):
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Experience with cell based or exosome based products.

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Experience coordinating or managing samples with outsourced/contract testing labs.

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Knowledge of method qualification or validation requirements.

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Experience writing deviations, OOS investigations, or validation protocols.

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Experience with aseptic processing and work in classified environments.

Work Environment & Physical Requirements:
• Laboratory‑based role.

• Work involves bench testing, aseptic handling, analytical instrumentation, and computer‑based documentation.

• Ability to lift up to 20 pounds.

• Occasional participation in meetings or cross‑functional discussions.

Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.