Scientist, Process Development-Downstream
PaxVax, Inc. is seeking a Scientist to work as part of the Process Development and Clinical Manufacturing teams whose primary focus is the development of downstream purification of virus/virus-like-particles with Ultrafiltration/diafiltration, Chromatography purification, and filtration methods. The Scientist role 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 downstream processes (chromatography, purification, diafiltration/ultrafiltration) for clinical supply production and to scale up these processes enabling transfer of robust processes to the commercial space. The successful candidate will work in a fast-paced team oriented environment learning new skills quickly. This position will report to the senior scientist leading the Downstream Processing.
- Develop and optimize downstream purification process for virus and virus-like-particles which includes:
- Tangential flow filtration
- Chromatography purification
- Sterile filtration
- Design the experiment, analyze the results for the virus/virus-like-particle yield improvement by DOE.
- Write technical reports, transfer the method and work to the clinical production team, support/generate the SOPs/batch record, and produce clinical trial materials
- Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing
- Mentor and train junior level associates
- Support upstream cell culture and bioreactor as needed
- Ph.D. degree or MS degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or a related field.
- MS degree with Minimum of 5 years of industry experience in the large molecular (virus, virus-like particle or equivalent) purification.
- Design of Experiment (DoE) is necessary
- Anion Exchange Purification experience is necessary
- Diafiltration/Ultrafiltration experience is necessary
- Self-motivated and detail oriented is a must
- Excellent written and verbal communication skills
- Excellent data analysis skills
- cGMP experience is preferred
- Molecular biology and virology knowledge is preferred
- Excellent aseptic techniques
- Bioreactor, Electroporation and Cell culture experience is a plus.
- Record of successful publication is a plus