Senior Scientist - Cell Therapy Product Characterization

AstraZeneca•Gaithersburg, MD

About The Position

The Senior Scientist will provide technical leadership in product characterization and potency method development for cell therapy products. This highly independent role combines cell therapy expertise, experimental judgment, and data automation to develop fit-for-purpose analytical methods, evaluate complex product datasets, and translate findings into scientific recommendations. The scientist will propose solutions, define study designs, and collaborate with research, process development, manufacturing, quality, and regulatory teams to advance programs from preclinical development through clinical stages. The role also leads technical discussions, supports investigations of atypical clinical lots, authors scientific and regulatory documentation, and mentors junior scientists. The position is based in Gaithersburg, Maryland. The annual base pay range is $112,304–$168,456, with eligibility for short-term incentive bonuses and equity-based awards for salaried roles. Benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

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, including the ability to manage multiple priorities, anticipate needs, propose solutions, and deliver results independently in a fast-paced development environment.
Proven expertise developing analytical methods to characterize potency, function, or mechanism of action of cell therapy products, such as cytotoxicity, proliferation, cytokine secretion, target-dependent activation, or 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, and ability to apply biological principles to cell therapy product characterization questions.
Ability to design experiments, analyze complex datasets, draw scientifically sound conclusions, and translate findings into recommendations, technical reports, and presentations.
Working knowledge of cell therapy development in an industry environment, including product quality attributes and 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 preparation of technical documents and communication of 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.

Nice To Haves

Proficiency in Python programming, 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 measuring cellular phenotype and function simultaneously.
Experience with spectral or imaging flow cytometry.
Demonstrated scientific leadership through mentoring, publications, patents, regulatory contributions, or cross-functional program leadership.

Responsibilities

Lead development and execution of potency methods to characterize cell therapy product function and mechanism of action.
Develop platform- and program-specific product characterization strategies and help define critical quality attributes.
Identify, evaluate, and implement analytical technologies, techniques, and instruments for assessing cell health, phenotype, and function.
Integrate and analyze 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 for visualizing and exploring complex product datasets.
Partner with process development teams to link process parameters to product quality attributes and assess the impact of process changes on product quality.
Serve as a product characterization and potency subject matter expert in investigations of out-of-specification or atypical clinical lots, recommending additional characterization as needed.
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 scientifically grounded recommendations to project teams and governance forums.
Anticipate scientific needs, define next steps, resolve technical challenges, and drive work to completion with limited direction.
Mentor junior scientists and contribute to a collaborative, safe, and scientifically rigorous laboratory culture.