Analytical Development Scientist - Cell Therapy

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 Analytical Development Scientist is a senior technical contributor within the Analytical Development team. This role leads the development, optimization, and validation of complex analytical methods supporting cell therapy and biologic products, operating with a high degree of independence and scientific judgment. The Scientist takes ownership of cross-functional projects, drives assay strategy, and ensures execution aligns with regulatory expectations and program timelines. This role contributes to technical decision-making, supports advancement of programs from early development through commercialization, and provides mentorship while fostering strong collaboration across teams.

Key Responsibilities :
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Develop, optimize, and validate analytical assays, including qPCR, RNAseq, flow cytometry, ELISA, and other cell-based functional assays to characterize cell therapy products

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Lead assay transfer activities between internal teams and external partners

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Design and execute experimental plans to meet project deliverables and timelines

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Author and review technical documents, including method development reports, SOPs, and CMC sections for regulatory filings

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Support regulatory submissions by generating and reviewing technical documentation

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Collaborate with cross-functional teams to support process development, product characterization, stability testing, and troubleshoot assay performance

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Apply Design of Experiment (DOE) approaches to establish robust, phase-appropriate analytical methods

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Provide scientific leadership and mentorship to junior scientists and foster a collaborative team culture

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Present data and insights at internal meetings and external conferences

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Stay updated on emerging analytical technologies to expand team capabilities

Minimum Qualifications:
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Ph.D. in Cell Biology, Molecular Biology, Immunology, Biochemistry, Bioengineering, or a related field

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2+ years of post-doctoral experience in analytical development for cell and gene therapies

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Strong expertise in a broad application of molecular and cell-based assays, including RNAseq, flow cytometry, qPCR, and other molecular biology techniques

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Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative environment

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Demonstrated experience mentoring junior scientists or leading projects in a team setting

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Strong organizational skills and ability to work collaboratively across disciplines

Preferred Qualifications:
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Hands-on experience in assay development, optimization, and validation in a GMP environment

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Experience in technology transfer processes between R&D and Quality Control or external partners

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Experience in authoring or reviewing CMC sections for IND/BLA submissions

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Familiarity with automation and high-throughput analytical platforms

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In-depth knowledge of regulatory requirements for cell therapy products, including FDA and EMA guidelines

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Knowledge of current trends and emerging technologies in cell therapy analytics

Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.