Process Engineer, Cell Therapy Process Development

Key Responsibilities

Process development andcharacterization

• 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.

PPQ, Tech Transfer & Manufacturing Readiness

• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support whenrequired).

• Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms.

Cross‑Functional Collaboration

• Work closely with analytical sciences and manufacturing science and technology teams to ensure end‑to‑end process alignment.

• Support lifecycle management, post‑approval changes, and continuous improvement initiatives forcell therapy processes.

Qualifications

• B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 3+ years of hands‑on industry experience; OR M.S. with 2+ years; OR Ph.D. with 0 years of 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 forcell 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.

• Familiarity with automation platforms (e.g.,CliniMACSProdigy, Lovo, G-Rex, Wave bioreactors).

• Experience implementing closed, automated, or high‑throughput systems.

• Experience designing and executing DOE and multivariate data analysis forcell therapyprocesses.

• Experience with JMP or similar statistical analysis tools.

• Formal training or demonstrated application of digitalization, automation, or AI‑enabled tools in bioprocess development.

The annual base pay for this position ranges from $79,336 to $119,005 . Our positions offer eligibility for various 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.