Senior Process Engineer, Cell Therapy Process Development

AstraZeneca

Gaithersburg, MD

Pay: $96,000-$144,000/yr

**Location** Gaithersburg, Maryland, United States **Job ID** R-264257 **Date posted** 11/11/2026

**Position Summary**

We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment.

The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness.

**Key Responsibilities**

**Process development and characterization**

• 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 risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums.
• Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters.
• 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.

**PPQ, Tech Transfer & Manufacturing Readiness**

• Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes.
• Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record.
• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
• Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.

**Regulatory Support**

• Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.
• Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.

**Cross‑Functional Collaboration**

• Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment.
• Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.
• Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes.

**Required Qualifications**

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience.
• Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation).
• 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, process characterization, and PPQ 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**

• Experience with viral vector handling (Lentivirus, AAV) in manufacturing processes.
• 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.
• Experience contributing to BLA/MAA submissions or regulatory interactions.
• Knowledge of control strategy development and risk assessment tools (e.g., FMEA).
• Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioproc