Quality Control Scientist

Capricor Therapeutics•San Diego, CA

21h•Onsite

About The Position

Capricor Therapeutics is a biotechnology company focused on developing cell and exosome-based therapies for rare diseases. The Quality Control Scientist will be a crucial member of the team at the San Diego facility, contributing to the mission of delivering innovative cell and regenerative therapies. This lab-based role is essential for enhancing the quality control framework by optimizing and validating analytical methods, managing technology transfers, and driving continuous improvement. The scientist will collaborate with cross-functional teams to support the development and commercialization of therapies, including cell-based products and exosomes, while adhering to strict regulatory standards. This position offers the chance to influence phase-appropriate QC strategies, implement new technologies, and positively impact patient outcomes through strong quality assurance.

Requirements

Bachelor’s degree in a relevant Biological Science discipline (Master’s or Ph.D. preferred).
7+ years of experience in a GMP Quality Control laboratory or GMP/GLP setting.
In-depth knowledge of FDA regulations, ICH guidelines, USP standards, and cGMP requirements for cell therapy or biologics.
Hands-on experience with laboratory methods including flow cytometry, Real-Time PCR, DNA isolation, ELISA, bioactivity assays, and sequencing.
Proven expertise in method qualification and validation.
Ability to independently perform laboratory analysis, troubleshoot, and improve methods.
Demonstrated history of successful, independent laboratory work.
Excellent communication skills and ability to collaborate effectively in a team environment.

Responsibilities

Optimize and troubleshoot QC methods to enhance performance, consistency, and efficiency.
Support method qualification, validation, and lifecycle management per regulatory expectations (ICH, USP, FDA).
Perform data trending and analysis to monitor assay performance and detect method variability or drift.
Collaborate with Analytical Development for seamless method transfers and onboarding of new assays into the QC laboratory.
Draft and review method SOPs, validation protocols/reports, and technical documentation.
Contribute to investigations, CAPAs, and continuous improvement initiatives within the QC function.
Evaluate and implement new technologies or instrumentation to improve assay robustness and throughput.
Provide technical documentation and SME input for regulatory inspections and audits.
Participate in risk assessments, gap analyses, and change control activities related to QC methods.
Train QC analysts on new or optimized assays to ensure consistent and compliant execution.
Author and review technical reports, method development summaries, and QC method lifecycle documents.
Maintain GMP documentation and laboratory practices with a strong lab-based presence.