Analytical Development Scientist - Cell Therapy

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 

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