Senior Scientist - Cell Therapy Product Characterization

Senior Scientist, Cell Therapy Product Characterization

Location: Gaithersburg, MD, US

Position Summary

We are seeking a highly independent Senior Scientist to provide technical leadership in product characterization and potency method development for cell therapy products. The successful candidate will combine expertise in cell therapy with strong experimental judgment and data automation capability to develop fit-for-purpose analytical methods, evaluate complex product datasets, and translate findings into clear scientific recommendations. This individual will proactively propose solutions, define experimental study design, and collaborate across teams from research, process development, manufacturing, quality, and regulatory functions to advance programs from preclinical development through clinical stages.

Key Responsibilities

• Lead the development and execution of potency methods used to characterize the function and mechanism of action of cell therapy products.

• Develop platform- and program-specific product characterization strategies and help define critical quality attributes of cell therapy products.

• Identify, evaluate, and implement new analytical technologies, techniques, and instruments to interrogate cell health, phenotype, and function.

• Integrate and interrogate process, product release, and product characterization data to identify trends, generate hypotheses, and recommend follow-up studies or actions.

• Develop automated data workflows, repositories, and dashboards to enable efficient visualization and exploration of complex product datasets.

• Partner with process development teams to link process parameters to product quality attributes and evaluate the impact of process changes on product quality.

• Serve as a product characterization and potency subject matter expert supporting investigations of out-of-specification or otherwise atypical clinical lots, including recommending additional characterization needed to assess product quality.

• Author method development reports, product characterization reports, SOPs, technical presentations, and sections of regulatory filings.

• Lead cross-functional technical discussions, communicate study outcomes, and provide clear, scientifically grounded recommendations to project teams and governance forums.

• Operate with a high degree of independence by anticipating scientific needs, defining next steps, resolving technical challenges, and driving work to completion with limited direction.

• Mentor junior scientists and contribute to a collaborative, safe,
• and scientifically rigorous laboratory culture.

Education and Experience

• PhD in Cell Biology, Immunology, Biomedical Engineering, Biotechnology, Biological Sciences, or a related discipline with at least 1 year of relevant experience; or MS with at least 4 years of relevant experience; or BS with at least 6 years of relevant experience.

• Demonstrated scientific leadership, initiative, organization, and accountability, with the ability to manage multiple priorities, anticipate needs, propose solutions, and deliver results independently in a fast-paced development environment.

• Proven expertise in developing analytical methods used to characterize potency/function/MoA of cell therapy products (e.g., cytotoxicity, proliferation, cytokine secretion, target-dependent activation, serial killing).

• Experience with multicolor flow cytometry, including panel design, experimental execution, troubleshooting, and complex data analysis.

• Advanced knowledge of T-cell biology and genetic engineering technologies, including the ability to apply biological principles to cell therapy product characterization questions.

• Demonstrated ability to design experiments, analyze complex datasets, draw scientifically sound conclusions, and translate findings into clear recommendations, technical reports, and presentations.

• Working knowledge of cell therapy development in an industry environment, including an understanding of cell therapy product quality attributes and the analytical approaches used to evaluate them.

• Experience leading complex experimental programs and working effectively in a cross-functional development environment.

• Excellent written and verbal communication skills, including the ability to prepare high-quality technical documents and communicate conclusions to cross-functional teams.

• Experience preparing technical content for regulatory submissions or responding to scientific questions from health authorities.

• Experience mentoring and/or managing junior scientists.

Desired Skills

• Proficiency in programming (Python), AI-assisted development, and data automation for integrating, structuring, analyzing, and visualizing complex scientific datasets.

• Experience with data repositories, statistical software, and other digital tools used in cell therapy development.

• Assay multiplexing experience, such as profiling multiple cytokines or simultaneously measuring cellular phenotype and function.

• Experience with spectral or imaging flow cytometry.

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