Capricor Therapeutics, Inc. · 1 month ago
Quality Control Analytical Scientist
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$90K/yr - $118K/yr
2+ years expCapricor Therapeutics is a biotechnology company focused on advancing cell and exosome-based therapies for rare diseases. The Quality Control Analytical Scientist will ensure high product quality at the San Diego facility by optimizing analytical methods and supporting the development of novel therapies while adhering to regulatory standards.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
Ph.D. in a relevant Biological Science discipline
2-5 years of experience in a GMP Quality Control laboratory or GMP/GLP setting
Hands-on experience with laboratory methods including flow cytometry, Real-Time PCR, DNA isolation, ELISA, bioactivity assays, and next generation sequencing
Knowledge of FDA regulations, ICH guidelines, USP standards, and cGMP requirements for cell therapy or biologics
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
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
Benefits
Health/dental/vision insurance
Paid time off
Parental leave
401k retirement plan
Company stock options
Bonus eligibility
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
MarketScreener
2025-12-17
Genetic Engineering News
2025-12-09
Company data provided by crunchbase