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.
Why Capricor?
Capricor Therapeutics is advancing cell and exosome-based therapies with a focus on serious diseases where patients and families need new treatment options. Our work is grounded in scientific rigor, collaboration, and a shared commitment to moving meaningful therapies forward. Joining Capricor means being part of a mission-driven team working at the intersection of innovation, execution, and patient impact.
Come Work With Us
At Capricor, you’ll join a collaborative environment where employees are encouraged to contribute, grow, and help build the systems, science, and operations needed to support our next stage of growth. We value people who are thoughtful, accountable, hands-on, and motivated by work that can make a real difference.
Recruiting Fraud Notice
Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by someone using an official Capricor email address ending in @capricor.com. Capricor will never ask candidates to send money, deposit a check, purchase equipment, or provide payment for any reason as part of the recruiting or onboarding process.
Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without express written approval from Talent Acquisition and a fully executed agreement with Capricor. Agencies that contact hiring managers directly, solicit business, or submit candidates without prior approval will not be considered for engagement. Any unsolicited submissions will become the property of Capricor Therapeutics, and no fees will be paid for candidates hired as a result of such submissions. We appreciate your cooperation and respect for this policy.
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.
