Associate Process Engineer, Cell Therapy Process Development

AstraZeneca; Santa Monica (CA); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Short-term incentives

Equity-based awards

Health, dental, vision coverage

Job summary

AstraZeneca plc in Santa Monica is seeking an Associate Process Engineer to support late-stage cell therapy process development and characterization activities, including cell isolation, activation, transduction, washes, and harvest using semi-automated or fully automated equipment. You will contribute to clinical and commercial readiness.

You will design and execute optimization studies, implement closed-system operations, perform DOE and QbD-aligned characterizations, analyze data, write

Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field; OR associate degree with 2+ years hands-on industry experience.
• Strong technical expertise in key cell therapy unit operations (cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologics.
• Experience with GMP operations and late-stage / commercial readiness.
• Ability to analyze complex datasets, develop recommendations, and communicate across levels.
• Experience with late-stage development and process characterization for cell therapy processes.
• Proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
• Experience in GMP environments, batch record execution/review, deviations and investigations.

Responsibilities

• Design, execute, and support autologous or allogeneic cell therapy process optimization and robustness studies.
• Drive implementation of closed-system operations and automation strategies for scalability and compliance.
• Plan and execute DOE and multivariate studies, scale-down/scale-up assessments, aligned with QbD and ICH guidelines.
• Perform data analysis, write technical reports, and present outcomes to cross-functional teams.
• Conduct batch record review, deviation assessment, and data trending to ensure process robustness.
• Apply AI-enabled tools to accelerate data review and process understanding.

Skills

Cell therapy ops

GMP experience

Data analysis

AI tools

Education

B.S. in Chemical/Biochemical Engineering or related field

Tools

JMP

CliniMACS Prodigy

Lovo

Wave bioreactors

Job description

Position Summary

We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, and BLA‑enabling studies. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi‑automated or fully automated equipment.Brings technical expertise, hands‑on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.

Key Responsibilities

• Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.
• Drive implementation of closed‑system operations and automation strategies to support scalability and compliance.
• Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines.
• Perform data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
• Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
• Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding.

Required Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field; OR associate degree. with 2+ years hands‑on industry experience.
• Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologics.
• Demonstrated experience with GMP operations and late‑stage / commercial readiness.
• Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels
• Experience with late‑stage development and process characterization principles for cell therapy processes.
• Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
• Experience working in GMP environments, including batch record execution or review, deviations, and investigations.
• Strong technical writing, data analysis, and problem‑solving skills.

Preferred Qualifications

• Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G‑Rex, Wave bioreactors).
• Experience implementing closed, automated, or high‑throughput systems.
• Experience designing and executing DOE and multivariate data analysis for cell therapy processes.
• Experience with JMP or similar statistical analysis tools.
• Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.

Key Competencies

• Experimental design and execution skills.
• Cross‑functional communication and collaboration.
• Ability to operate effectively in fast‑paced, late‑stage development environments.
• Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.

Annual Base Pay

The annual base pay for this position ranges from $67K to $101K.

Our positions offer eligibility for multiple 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.

#Cell Therapy

Date Posted

29-Oct-2026

Closing Date

05-Nov-2026

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.