Quality Control Associate - Analytical

Capricor Therapeutics•San Diego, CA

2d•$75,000 - $85,000•Onsite

About The Position

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 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. As a key member of the analytical team, you will execute complex assays and manage mammalian cell cultures essential for determining product potency and characterization. You will be responsible for ensuring that all data is recorded with the highest level of integrity in GMP-compliant systems while proactively supporting investigations into any atypical results. Working in this hands-on bench role, you will collaborate cross-functionally with development and manufacturing partners to ensure testing readiness and drive continuous improvement across our analytical operations.

Requirements

Bachelor’s degree in Biological Sciences or related field.
2+ years of experience in a GMP QC laboratory or GMP/GLP environment.
Hands‑on experience with mammalian cell culture.
Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies.
Strong GMP documentation, data integrity, and compliant data recording skills.
Ability to work independently, manage multiple testing assignments, and meet tight timelines.

Nice To Haves

Experience with cell‑based or exosome‑based products.
Experience coordinating or managing samples with outsourced/contract testing labs.
Knowledge of method qualification or validation requirements.
Experience writing deviations, OOS investigations, or validation protocols.
Experience with aseptic processing and work in classified environments.

Responsibilities

Perform QC analytical testing on in‑process materials, bulk drug substances, and final products to support batch release and stability programs.
Maintain and prepare mammalian cell cultures used in potency or characterization assays.
Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA‑based methods.
Analyze data, generate results, and enter findings into QC systems and reports.
Document all work in accordance with GMP and data integrity standards, including batch records, lab notebooks, and controlled forms.
Communicate test results, issues, or atypical findings to QC leadership and development partners.
Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates.
Assist with assay troubleshooting in collaboration with Process and Analytical Development.
Train team members on relevant lab techniques or QC procedures.
Support updates to QC SOPs and continuous improvement initiatives.
Manage testing priorities to meet project timelines and operational needs.
Perform additional QC duties as assigned.