Poseida is seeking a highly capable and independent Process Engineer II to join our Process Development team to develop novel cell processing platforms to support Poseida’s allogeneic cell therapy programs. He/She will work to improve the current process and develop a number of cutting-edge technologies in constant pursuit of the best possible way to deliver our proprietary technology (i.e., electroporation, microfluidics, etc.) The successful candidate will engage his/her engineering knowledge/experience to develop/improve bioreactor design, fluid management single use aseptic technologies and improve process by using risk-based modeling approach. He/She will work in conjunction with a team of scientists to develop, optimize, scale-up, and characterize in-process, upstream and downstream methods to improve critical variables in the development process. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Presents study results at team or department meetings, to external partners, and at conferences. Position requires excellent communication and presentation skills, a proven ability to plan and carry out experiments independently, troubleshoot technical issues, and to work with automation instrumentation and software. The position will be based out of the newly created process development group and given an opportunity to contribute to the development of overall CMC project strategies.
Responsibilities may include but are not limited to:
· Develop and/or improve commercialization ready cell processing platform using advance technologies.
· Develop/improve cell therapy product/process using Quality by Design (QbD) principle and Lean Six Sigma methodology.
· Develop a robust automated, closed/semi-closed manufacturing platform by using industry standard state of art technologies.
· Optimize/troubleshoot production processes to improve production yield consistent with safety and quality parameters and coordinate with potential resolution with CMC team.
· Develop/improve scale up technologies to deliver transposon/transposase constructs into T cells by electroporation and other non-viral gene delivery systems.
· Evaluate alternative technologies (i.e., bioreactor system – Wave, Ambr, Xuri, CliniMACS Prodigy, Sepax) to create robust, reproducible, and scalable next generation manufacturing processes.
· Work with R&D teams to gain deeper understanding of the process challenges and of the process-to-process product quality attributes variability.
· Independently design and execute process development studies using Design of Experiment (DOE).
· Analyze data, communicate results, and author technical reports.
· Assist in the development of standard operating procedures and technology transfer to internal or external manufacturers.
· Present ideas and data in team meeting and cross-functional meetings. Be an active participant and intellectual leader.
Requirements, Knowledge, Skills and Abilities:
· Bachelor’s degree in Biochemical, Chemical, Biomedical Engineering or related scientific field with 6 years of relevant Process Development experience or Master’s degree with at least 4 years of relevant Process Development experience.
· The ideal candidate will have at least 3 years working in a GMP biotech industry environment.
· Prior GMP Cell/Gene therapy and/or biologics manufacturing experience for clinical/commercial stage products is required.
· Experience with single-use systems such as bioreactors, purification columns preferred.
· Solid knowledge of cGMP principles, ICH, FDA and EU guidance documents, and quality systems.
· Training in Design of Experiment (DoE), Six Sigma lean manufacturing preferred
· Proficient with timeline development and project tracking
· Willingness to think outside the box, be creative and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
· Travel may be required up to 10-20% of the time.
· Must be physically capable to lift 50 pounds.
Apply at: https://recruiting.paylocity.com/recruiting/jobs/Apply/439077/Poseida-Therapeutics-Inc/Process-Development-Engineer-II