Capricor Therapeutics
Biotech
QualityControlScientist,Controls
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Control Scientist, Controls at Capricor Therapeutics. Skills: Control materials development, Assay control strategies, Analytical studies execution. Lead development of control materials. Lead qualification of control materials”
Industry & Context.
Troubleshooting; Method optimization
Laboratory-based role, Routine bench work, Lift up to 20 pounds
What They're Looking For.
Must Have
Ph.D. in Biological Sciences, Biochemistry, Molecular Biology, Bioengineering, or related discipline, Background in primary cell culture, Analytical assay development experience, Troubleshooting experience, Experimental design experience, Hands-on experience with ELISA, Hands-on experience with PCR/qPCR, Hands-on experience with flow cytometry, Hands-on experience with biochemical assays, Hands-on experience with cell-based assays, Experience designing analytical studies, Experience executing analytical studies, Experience interpreting experimental data, Understanding of assay controls, Understanding of assay performance monitoring, Understanding of analytical method lifecycle management, Written communication skills, Verbal communication skills, Ability to work independently, Manage multiple scientific projects
Nice to Have
Experience in GMP laboratory, Experience in regulated laboratory, Support analytical method qualification, Support analytical method validation, Support analytical method lifecycle management, Experience with cell-based assays, Experience with mammalian cell culture, Support deviations, Support assay investigations, Support technical reports in regulated environments, Experience with cell therapy products, Experience with biologics products, Experience with exosome-based products
What You'll Do.
Lead development of control materials
Lead qualification of control materials
Lead maintenance of control materials
Establish assay control strategies
Oversee assay control strategies
Serve as scientific owner for control materials
Manage control material lifecycle
Design analytical studies
Execute analytical studies
Evaluate assay performance
Evaluate control suitability
Evaluate assay robustness
Evaluate method reliability
Provide scientific leadership for troubleshooting
Provide scientific leadership for optimization
Improve assay robustness
Improve assay reproducibility
Evaluate assay performance trends
Evaluate control performance data
Identify opportunities for improving reliability
Analyze experimental data
Generate scientific reports
Generate study summaries
Generate technical documentation
Document experimental work
Document study outcomes
Support preparation of technical documentation
Support maintenance of technical documentation
Support regulatory inspection readiness
Ensure control strategies meet expectations
Ensure documentation meets expectations
Ensure study records meet expectations
Provide scientific support for investigations
Support assay performance issues
Collaborate with Analytical Development
Collaborate with Process Development
Collaborate with Manufacturing
Collaborate with Quality teams
Support assay lifecycle management
Support continuous improvement initiatives
Manage scientific projects
Manage project timelines
Perform additional QC duties
How You'll Work.
Team & Collaboration
Quality Control; Analytical Development; Process Development; Manufacturing; Quality teams
Communication Scope
Summarize scientific findings
Process & Methodology
Manage multiple projects
Full Job Description
## 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 rob
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