Summary Description of Role:
PaxVax, Inc. is seeking a PH.D. or Post Doc to join the Process Development and Clinical Production department. The successful candidate will be expected to work as part of a team that is focused on the process development for vaccine development from preclinical through Phase III, and commercialization. The main responsibilities will include the design, execution, and documentation of experiments to develop/optimize upstream (bioreactor, transfection, microfiltration, filtration) for clinical supply production and to scale up these processes to enable transfer of robust processes to the commercial space. The successful candidate will be able to work in a fast-paced team environment and be able to learn new skills quickly. The candidate at PaxVax will be a key member of the Process Development team and will report to the director of process and production development.
Develop and optimize the viral amplification/virus-like-particle transient transfection process to maximize the yield.
Develop and optimize the microfiltration process to concentrate the cells for viral amplification/virus-like-particle transient transfection.
Use DOE software to design the experiment, analyze the results for the virus/virus-like-particle yield improvement.
Write technical reports and transfer the method and work with clinical production team to support/generate the SOPs/batch record and produce the clinical trial materials.
Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing.
Support downstream purification team for the development work (tangential flow filtration, anion exchange chromatography purification and sterile filtration) and clinical trial material production as needed.
Guide/train junior level associates
Technical Skills and Knowledge:
· Cell culture experience is necessary
· Bioreactor experience is necessary
· Design of Experiment (DoE) is necessary
· Anion Exchange Purification experience is preferred
· Diafiltration/Ultrafiltration experience is preferred
· Good data anaylsis skills
· Good aseptic techniques
· Good writing skills