Analytical Development Scientist - Cell Therapy

Capricor Therapeutics • San Diego, CA

1d • $110,000 - $120,000

About The Position

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

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