Senior Scientist - Cell Therapy Product Characterization

AstraZeneca plc; Gaithersburg (MD); On-site; USD 112,000 - 168,000; Full time

Benefits offered by this job

Health, dental, and vision coverage

Paid time off (vacations, holidays)

Incentives and equity opportunities

Job summary

AstraZeneca plc in Gaithersburg, MD seeks a highly independent Senior Scientist to lead potency method development for cell therapy products. The role requires designing experiments, leading cross-functional teams, and translating data into actionable recommendations.

The candidate will build automated workflows and collaborate across research, process development, manufacturing, quality, and regulatory functions to advance programs from preclinical through clinical stages.

Qualifications

• Leadership and initiative to manage multiple priorities in fast-paced development
• Proven ability to develop analytical methods to characterize potency/MoA of cell therapy products
• Experience designing experiments, analyzing complex data, and delivering clear reports
• Proficiency in programming (Python) and data automation for scientific datasets
• Experience with multicolor flow cytometry, panel design, and complex data analysis
• Familiarity with cell therapy development and product quality attributes
• Experience mentoring junior scientists and writing technical/regulatory content
• Ability to communicate findings to cross-functional teams and regulatory bodies

Responsibilities

• Lead development and execution of potency methods to characterize function of cell therapy products
• Develop platform- and program-specific characterization strategies and define CQAs
• Identify and implement new analytical technologies and instruments
• Integrate process, release, and characterization data to identify trends and recommend actions
• Develop automated data workflows, repositories, and dashboards for visualization
• Link process parameters to product quality attributes and assess impact of changes
• Serve as SME for investigations and determine additional characterization needs
• Author method development reports, characterization reports, SOPs, and regulatory submissions sections
• Lead cross-functional technical discussions and communicate outcomes clearly
• Operate independently, anticipate needs, and drive work to completion
• Mentor junior scientists and promote rigorous lab culture

Skills

Python programming

AI-assisted development

Data automation

Data repositories

Statistical software

Assay multiplexing

Spectral imaging flow cytometry

Scientific leadership

Education

PhD in Cell Biology, Immunology, Biomedical Engineering, Biotechnology, Biological Sciences, or related with ≥1 year

MS with ≥4 years relevant experience

BS with ≥6 years relevant experience

Job description

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.
• Demonstrated scientific leadership through mentoring, publications, patents, regulatory contributions, or cross-functional program leadership.

Compensation

The annual base pay (or hourly rate of compensation) for this position ranges from $112,304 - $168456. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

25-Oct-2026

Closing Date

26-Nov-2026

Equal Opportunity Statement

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.