Senior Scientist - Cell Therapy Product Characterization

AstraZeneca • Gaithersburg, MD

1d • $112,304 - $168,456 • Onsite

About The Position

The Senior Scientist will provide technical leadership in product characterization and potency method development for cell therapy products. The 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 position requires working independently to anticipate scientific needs, resolve technical challenges, and drive work to completion with limited direction. The successful candidate will also mentor junior scientists and contribute to a collaborative, safe, and scientifically rigorous laboratory culture.

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.
• 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.
• 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 the ability to apply biological principles to cell therapy product characterization.
• 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 simultaneously measuring cellular phenotype and function.
• Experience with spectral or imaging flow cytometry.
• Scientific leadership demonstrated through mentoring, publications, patents, regulatory contributions, or cross-functional program leadership.

Responsibilities

• Lead development and execution of potency methods 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 analytical technologies, techniques, and instruments to assess 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 visualization and exploration of complex product datasets.
• Partner with process development teams to connect process parameters to product quality attributes and evaluate the effects 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, including recommending additional characterization 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 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.

Benefits

• Eligibility for short-term incentive bonuses.
• Equity-based awards for salaried roles.
• Qualified retirement programs.
• Paid time off, including vacation, holidays, and leaves.
• Health coverage.
• Dental coverage.
• Vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior