Key responsibilities
* develop,optimize, andvalidateanalytical 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 toestablishrobust, 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
minimum qualifications
* 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
* strongexpertiseina broad application of molecular andcell-based assays,includingrnaseq,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
preferred qualifications
* hands-on experience in assay development, optimization, and validation in a gmp environment
* experience in technology transfer processes between r&d and quality controlor external partners
* experience in authoringorreviewing 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
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