Process Engineer, Cell Therapy Process Development

About the Company

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 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 when required).
• ● 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 for cell therapy processes.
• ● Required Qualifications
• ● M.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; 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) 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
• ● Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.
• ● Strong technical writing, data analysis, and problem solving skills.

Requirements

• ● Familiarity with automation platforms (e.g., CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors).
• ● 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.
• ● The annual base pay for this position ranges from 81K to 122K. 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 .
• ● Hybrid Cell Therapy
• ● Date Posted 22-Sep-2026
• ● Closing Date 08-Oct-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.