Job Overview We are seeking a highly motivated and detail-oriented Process Engineer II with hands-on experience in cell therapy process development to support innovative T-cell therapies for cancer treatment. This role is part of the Autologous Process Design and Development / Life Cycle Management Team and will focus on developing, optimizing, and transferring cell therapy manufacturing processes and technologies. The successful candidate will work closely with Research, Process Development, Engineering, Quality, and GMP Manufacturing teams to evaluate new technologies, improve existing processes, and support clinical and commercial manufacturing. The ideal candidate combines strong cell culture and aseptic processing skills with experience in process development, bioreactors, automated cell therapy platforms, statistical analysis, and GMP manufacturing . Key Responsibilities Design and execute laboratory experiments supporting cell therapy process development, characterization, optimization, and technology implementation . Perform hands-on activities in a cell culture laboratory, including cell passaging, sampling, fluid handling, media preparation, reagent management, and cryopreservation . Conduct cell therapy process development studies using automated cell therapy platforms . Evaluate and implement new technologies, equipment, materials, and process solutions for clinical and commercial GMP manufacturing. Analyze process and equipment performance, identify trends, troubleshoot issues, and recommend improvements. Support the development and optimization of manufacturing equipment, including hardware, software, single-use components, and user requirements . Apply engineering and scientific principles to scale-up/scale-out, bioreactor operation, hydrodynamics, mass transfer, and process monitoring . Perform statistical analysis using tools such as JMP and Minitab , including Design of Experiments (DOE) where appropriate. Support technology transfer and GMP manufacturing operations . Provide process and technical training to GMP manufacturing personnel. Prepare, review, and maintain technical documentation, including SOPs, manufacturing batch records, protocols, technical reports, and summary reports . Analyze experimental data and prepare presentations for cross-functional teams, senior leadership, stakeholders, and external collaborators . Work collaboratively across Research, Development, Engineering, Quality, and Manufacturing teams in a fast-paced environment. Perform additional duties and responsibilities as assigned. Required QualificationsEducation & Experience Master's degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline with 2+ years of pharmaceutical/biotechnology manufacturing or process development experience; OR Bachelor's degree in a related engineering, biotechnology, or life sciences discipline with 4+ years of relevant experience; OR Associate degree in a related discipline with 5+ years of relevant pharmaceutical/biotechnology manufacturing or process development experience; OR High School Diploma with 6+ years of relevant pharmaceutical/biotechnology manufacturing or process development experience. Required Technical Experience Hands-on experience with cell therapy process development , preferably involving T-cell therapies . Experience working with automated cell therapy platforms . Strong cell culture and aseptic processing experience in an ISO 5 environment . Experience with cell culture activities such as cell passaging, sampling, fluid handling, media formulation, reagent management, and cryopreservation . Practical knowledge of cGMP manufacturing and pharmaceutical/biotechnology regulatory requirements. Hands-on experience with process development, bioreactors, and Design of Experiments (DOE) . Strong understanding of bioprocessing principles, including scale-up/scale-out, hydrodynamics, mass transfer, bioreactor design, and process monitoring . Understanding of cell biology , including cell sub-populations, differentiation, phenotype markers, and metabolic pathways. Knowledge of materials science and material compatibility for cell culture applications. Experience with biotechnology product manufacturing, aseptic processing, cell therapy manufacturing, and process development . Strong analytical, troubleshooting, and problem-solving abilities. Ability to work independently with minimal direction while effectively managing changing priorities. Preferred Qualifications Experience with flow cytometry . Experience with mRNA handling and mRNA-based processes . Experience supporting technology transfer into GMP manufacturing . Experience with automated manufacturing technologies and single-use systems. Experience preparing technical documentation for regulatory submissions or filings .

Pay:

$50.00 - $57.00 per hour Expected hours: 40.0 per week

Experience:

Cell culture: 2 years (Required)

Work Location:

In person