Overview
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, Controls will support 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, performing analytical studies to evaluate assay performance, and supporting troubleshooting and optimization of analytical methods used in QC testing.This position plays an important role in ensuring the reliability and consistency of QC assays by supporting the generation, characterization, and maintenance of assay controls. The individual will work closely with QC scientists and cross-functional teams to support assay performance monitoring and continuous improvement of analytical methods used across Capricor’s therapeutic programs.
Responsibilities
- Generate, prepare, and maintain positive and negative control materials used in QC analytical assays.
- Support the qualification and characterization of control materials to ensure suitability for routine QC testing.
- Execute analytical assays to support control evaluation, assay troubleshooting, and assay optimization studies.
- Perform laboratory activities related to control generation, characterization, and assay performance evaluation.
- Maintain inventory, traceability, and documentation of assay control materials used across QC testing programs.
- Analyze experimental data, summarize results, and document findings in accordance with GMP and data integrity requirements.
- Document all laboratory work in GMP-compliant systems including laboratory notebooks, controlled forms, and electronic records.
- Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, and control qualification records.
- Assist with investigations related to assay performance including deviations, OOS/OOT events, and atypical assay results.
- Collaborate with QC scientists and cross-functional teams including Analytical Development, Process Development, Manufacturing, and Quality to support assay readiness and continuous improvement initiatives.
- Manage multiple laboratory assignments and testing priorities to meet project timelines and QC operational needs.
- Perform additional QC duties as assigned.
Required Qualifications (Must‑Haves)
- Bachelor’s degree in Biological Sciences, Biochemistry, Molecular Biology, or a related discipline.
- 2+ years of laboratory experience in biotechnology, pharmaceutical, or GMP-regulated environments.
- Hands-on experience performing analytical assays such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell-based assays.
- Experience preparing or maintaining assay controls or reference materials.
- Strong laboratory documentation practices and familiarity with GMP and data integrity expectations.
- Ability to analyze data and communicate findings clearly.
- Ability to work independently and manage multiple assignments in a laboratory environment.
- Strong organizational and time management skills.
Preferred Qualifications (Nice‑to‑Haves)
- Experience supporting analytical studies related to assay performance or assay optimization.
- Experience working with mammalian cell culture or cell-based assays.
- Experience supporting method qualification or assay performance monitoring activities.
- Experience supporting deviations, investigations, or technical reports in regulated environments.
- Experience working 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.
