Senior Cell Therapy Scientist - Potency & Characterization Lead

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

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.