Quality Control Scientist, Controls

Job Description

Job Description

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 Scientist, Controls will lead 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, designing and executing analytical studies, and troubleshooting and optimizing analytical methods used in QC testing. 

 

This position plays a critical role in ensuring assay reliability, reproducibility, and regulatory compliance within the QC laboratory. The individual will provide scientific leadership for assay control strategies, oversee analytical lifecycle activities for control materials, and collaborate with Quality Control, Analytical Development, Process Development, Manufacturing, and Quality teams to ensure robust analytical readiness across Capricor’s therapeutic programs. 

Responsibilities

• Lead the development, qualification, and maintenance of positive and negative control materials used in QC analytical assays.
• Establish and oversee assay control strategies to ensure reliable assay performance and consistency across QC testing programs.
• Serve as the scientific owner for control materials within the analytical lifecycle framework, including control generation, qualification, monitoring, and lifecycle management.
• Design and execute analytical studies to evaluate assay performance, control suitability, assay robustness, and method reliability.
• Provide scientific leadership for assay troubleshooting and optimization activities to improve assay robustness and reproducibility.
• Evaluate assay performance trends and control performance data to identify opportunities for improving assay reliability.
• Analyze experimental data, interpret results, and generate scientific reports, study summaries, and technical documentation.
• Document experimental work and study outcomes in accordance with GMP and data integrity requirements.
• Support preparation and maintenance of technical documentation including study protocols, reports, SOP updates, control qualification records, and analytical lifecycle documentation.
• Support regulatory inspection readiness by ensuring analytical control strategies, documentation, and study records meet regulatory expectations. 
• Provide scientific support for investigations including deviations, OOS/OOT events, and assay performance issues.
• Collaborate with Analytical Development, Process Development, Manufacturing, and Quality teams to support assay lifecycle management and continuous improvement initiatives.
• Manage multiple scientific projects and timelines to support QC laboratory priorities.
• Perform additional QC duties as assigned. 

Required Qualifications (Must‑Haves)

• Ph.D. in Biological Sciences, Biochemistry, Molecular Biology, Bioengineering, or a related discipline.
• Strong background in primary cell culture and analytical assay development, troubleshooting, and experimental design.
• Hands-on experience with analytical techniques such as ELISA, PCR/qPCR, flow cytometry, or other biochemical or cell-based assays.
• Experience designing and executing analytical studies and interpreting experimental data.
• Strong understanding of assay controls, assay performance monitoring, and analytical method lifecycle management.
• Strong written and verbal communication skills with the ability to clearly summarize complex scientific findings.
• Ability to work independently and manage multiple scientific projects in a fast-paced environment. 

Preferred Qualifications (Nice‑to‑Haves)

• Experience working in GMP or regulated laboratory environments.
• Experience supporting analytical method qualification, validation, or lifecycle management.
• Experience working with cell-based assays or mammalian cell culture systems.
• Experience supporting deviations, assay investigations, or technical reports in regulated environments.
• Experience 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. 

Compensation and Benefits

The posted salary range represents Capricor’s good-faith estimate of the salary range reasonably expected to be paid for this position at the time of hire. Final compensation will be determined based on job-related factors, including the candidate’s relevant experience, education, skills, certifications, scope of role, location, and internal equity.

This position may also be eligible for a discretionary annual performance bonus and, depending on the level of the role, long-term equity incentive awards in accordance with company policy.

Capricor Therapeutics offers a comprehensive benefits package that includes employer-sponsored medical, dental, and vision coverage; company-paid basic life and AD&D insurance; a 401(k) plan with company match; paid time off and company holidays; and paid parental leave. Additional voluntary benefits and wellness programs may also be available.

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.