The Quality Control Scientist will be a key contributor to Capricor’s mission of delivering innovative cell and regenerative therapies, ensuring the highest standards of product quality at our San Diego facility. This lab-based role is critical in advancing our quality control framework by optimizing and validating analytical methods, facilitating seamless technology transfers, and driving continuous improvement initiatives. The scientist will work closely with cross-functional teams to support the development and commercialization of novel therapies, including cell-based products and exosomes, while ensuring compliance with stringent regulatory standards. This position offers a unique opportunity to shape phase-appropriate QC strategies, implement cutting-edge technologies, and directly impact patient outcomes through robust quality assurance.
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.
Required Qualifications (Must‑Haves)
- 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.
Work Environment & Physical Requirements
- Must be able to sit or stand for extended periods, move around the facility, communicate effectively, and lift/carry up to 40 lbs.
- Ability to gown and work in a classified area as required.
Skills Required
- 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, and sequencing
- Proven expertise in method qualification and validation
- Ability to independently perform laboratory analysis, troubleshoot, and improve methods
- Excellent communication skills and ability to collaborate effectively in a team environment
What We Do
Capricor Therapeutics is a clinical-stage biotechnology company focused on the discovery, development, and commercialization of cell and exosome-based therapeutics. Its lead product candidate, Deramiocel, is an allogeneic cell therapy currently in late-stage clinical development for the treatment of Duchenne muscular dystrophy (DMD). The company also leverages its proprietary StealthX™ exosome platform for the targeted delivery of therapeutic agents to treat a wide range of diseases.
