Analytical Development Scientist - Cell Therapy

Key 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 

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 

• 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 

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 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