Analytical Development Scientist - Cell Therapy
About The Position
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.
Requirements
- Ph.D. in Cell Biology, Molecular Biology, Immunology, Biochemistry, Bioengineering, or a related field
- 2+ years of post-doctoral experience in analytical development for cell and gene therapies
- Strong expertise in a broad application of molecular and cell-based assays, including RNAseq, flow cytometry, qPCR, and other molecular biology techniques
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative environment
- Demonstrated experience mentoring junior scientists or leading projects in a team setting
- Strong organizational skills and ability to work collaboratively across disciplines
Nice To Haves
- Hands-on experience in assay development, optimization, and validation in a GMP environment
- Experience in technology transfer processes between R&D and Quality Control or external partners
- Experience in authoring or reviewing CMC sections for IND/BLA submissions
- Familiarity with automation and high-throughput analytical platforms
- In-depth knowledge of regulatory requirements for cell therapy products, including FDA and EMA guidelines
- Knowledge of current trends and emerging technologies in cell therapy analytics
Responsibilities
- Develop, optimize, and validate analytical assays, including qPCR, RNAseq, flow cytometry, ELISA, and other cell-based functional assays to characterize cell therapy products
- Lead assay transfer activities between internal teams and external partners
- Design and execute experimental plans to meet project deliverables and timelines
- Author and review technical documents, including method development reports, SOPs, and CMC sections for regulatory filings
- Support regulatory submissions by generating and reviewing technical documentation
- Collaborate with cross-functional teams to support process development, product characterization, stability testing, and troubleshoot assay performance
- Apply Design of Experiment (DOE) approaches to establish robust, phase-appropriate analytical methods
- Provide scientific leadership and mentorship to junior scientists and foster a collaborative team culture
- Present data and insights at internal meetings and external conferences
- Stay updated on emerging analytical technologies to expand team capabilities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
