• Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development experience required.
• Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
• Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
• Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments is required.
• Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals.
• Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
• Knowledge of material science and material compatibility for cell culture applications
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
• Ability to think critically, troubleshoot, and problem solve in a timely manner.
• Excellent interpersonal, verbal and written communication skills are required.
• Ability to function efficiently and independently in a changing environment.
• Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills.
• High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to work and collaborate in a fast pace dynamic cross-functional team setting across research, development, and manufacturing departments.
• 1 to 3 years of pharmaceutical process development experience.
• GMP manufacturing of pharmaceutical products.
• Cell culture aseptic processing, experience with cell therapy products is a plus.
• Use of principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus.
• Statistical analysis using JMP or Minitab.
• Proven track record of working within cross functional teams.
• Knowledge of data management tools and statistical process controls.
• Experience performing process design and process automation is a plus.
• Experience interpreting blueprints, PFDs, P&IDs, AutoCAD, PLC, and creating process flow maps.
Client is seeking a highly motivated individual who's detail-oriented and knowledgeable in cell culture to develop innovative technologies for the manufacture of cancer targeting T cell therapies. As a Process Engineer I, you will be responsible for designing and executing engineering activities and lab studies in support of process automation, technology development, technology evaluation, equipment qualification, process validation, and GMP manufacturing. Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings. You will work within the process technology and materials development team to design and scale-out cell therapy processes, evaluate new materials, implement innovative solutions, and support or improve existing technologies to advance Client's product portfolio. You will work closely with analytical, process design, validation, manufacturing sciences, operations, business strategy, and external collaborators as needed to achieve the above objectives.
• Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.
• Perform hands-on lab-based activities in a cell culture lab, including conception of study designs, analysis of data and communication of results to cross-functional project teams.
• Perform process or equipment analysis and trend process or equipment performance.
• Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
• Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
• Provide process training to GMP manufacturing personnel.
• Support technology transfer and GMP manufacturing operations as needed.
• Perform statistical analysis including design of experiments (DOEs) as appropriate.
• Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
• Support qualification, risk assessment, and validation activities as technologies advance closer to deployment at GMP clinical and/or commercial manufacturing.
• Create and present slides with supporting data to communicate results to senior leadership or external collaborators.
• Perform other duties as assigned.