Capricor Therapeutics

Biotech

QualityControlScientist,Controls

$95–115k San Diego, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Biotech
Problems you'll solve

Troubleshooting; Method optimization

Eligibility Requirements

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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