Senior Process Engineer, Cell Therapy Process Development

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 bioprocess development.

Key Competencies

• Strong experimental design and execution skills.
• Excellent 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.