Senior Director, Cell Therapy Process Development (Hybrid)

AstraZeneca; Santa Monica (CA); Hybrid; USD 138,000 - 207,000; Full time

Benefits offered by this job

Short-term incentives

Equity awards

Retirement plan

Health insurance

Paid time off

Job summary

AstraZeneca is seeking an Associate Director of Late-Stage Cell Therapy Process Development to lead a team of scientists and engineers from clinical development through commercialization. You will partner with Manufacturing, Quality, Regulatory, Analytical Development, and CMC to ensure robust, scalable manufacturing processes.

The role requires strong scientific leadership in late-stage development, PPQ, technology transfer, and lifecycle management, with AI and digital analytics applied to

Qualifications

• PhD in related field with 6+ yrs, or MS 10+ yrs, or BS 12+ yrs in industry.
• Strong expertise in cell therapy process development and GMP operations.
• Experience with PPQ, tech transfer, and lifecycle management.

Responsibilities

• Lead late-stage process development for cell therapies and manage multiple projects.
• Direct engineers/scientists to deliver study design docs and reports.
• Perform risk assessment, data analysis, and present studies to cross-functional teams.
• Coordinate batch record review, deviations, and data trending for robust processes.
• Apply AI and digital analytics to accelerate data review and process understanding.
• Support PPQ, technology transfer, and post-approval changes.

Skills

Cell therapy process development

GMP operations

Late-stage development

AI tools for data analysis

Technical writing

Education

Ph.D. in Chemical Engineering or related field

Tools

Digital analytics tools

Design of Experiments (DOE)

Job description

AstraZeneca is seeking an Associate Director of Late-Stage Cell Therapy Process Development to lead a team of scientists and engineers from clinical development through commercialization. You will partner with Manufacturing, Quality, Regulatory, Analytical Development, and CMC to ensure robust, scalable manufacturing processes.

The role requires strong scientific leadership in late-stage development, PPQ, technology transfer, and lifecycle management, with AI and digital analytics applied to