Process Engineer, Cell Therapy Process Development
Overview:
In this role you will advance late-stage cell therapy process development, characterization, and BLA-enabling studies. You will work on cell therapy unit operations with both semi-automated and fully automated equipment, driving scalable, compliant processes. You'll design and analyze experiments, support tech transfer and manufacturing readiness, and apply digital tools to accelerate insights. This is an impact-driven position that spans development to commercial readiness within a fast-paced, cross-functional environment. Compensation / Benefitsqualified retirement programspaid time off (vacation, holiday, leaves)health, dental, and vision coverageincentives and short-term incentive bonusesequity-based awards for salaried rolescommissions for sales roles
Responsibilities:
- Design and optimize autologous/allogeneic cell therapy processes for robustness
- Implement closed-system operations and automation for scale-upPlan and execute DOE/multivariate studies and scale-down/up assessments per QbD/ICHAnalyze data, prepare technical reports, present results to cross-functional teams
- Perform batch record review, deviations, and data trending to ensure robustness
- Apply AI and digital analytics to accelerate data review and process understanding
- Provide on-the-floor technical support during scale-up, engineering runs, PPQ, and campaigns
- Support raw material risk assessments, comparability studies, and cross-facility risk evaluations
- Collaborate with analytical sciences and manufacturing science teams for end-to-end alignment
- Support lifecycle management, post-approval changes, and continuous improvement initiatives
Key requirements:
- MS in relevant field with 2+ years industry experience or BS with 7+ years industry experience
- Strong expertise in cell therapy unit operations (isolation, activation, transduction, expansion, harvest, formulation, cryopreservation) or biologicsGMP experience and familiarity with late-stage/commercial readiness
- Ability to analyze complex datasets and communicate recommendations across levels
- Experience with late-stage development and process characterization for cell therapy
- Proficiency in applying AI tools and digital solutions to data analysis and automationGMP batch record execution or review, deviations and investigations
- Strong technical writing, data analysis, and problem-solving skills
- Excellent cross-functional communication
- Collaborative mindset and teamwork
- Ability to operate in fast-paced, late-stage environments
- Automation platforms familiarity (CliniMACS Prodigy, Lovo, G-Rex, Wave bioreactors)DOE and multivariate data analysis
- Experience with JMP or similar tools