The Therapeutic Production and Quality department is looking for a Sr. Scientist I Process Development to design and implement process development experiments with minimal supervision, both upstream and downstream unit operations. In this role you will perform small scale culture experiments, set up and run bioreactors for culture of mammalian or bacterial cells, and optimize purification methods using various chromatography techniques. Experience in mammalian cell culture, bioreactors, protein purification, tangential flow filtration and various other filtration techniques is preferred. You will generate monoclonal antibodies, recombinant proteins, and gene therapy vectors including Lentiviral and AAV vectors.
• Maintain processes according to the requirements for drug substances and drug products as mandated by the FDA, EMA and MHRA,
• Maintain excellent electronic note booking skills and generate reports that summarize all process development activities.
• Develop production batch records based process development activities in collaboration with the Quality Assurance Department of Childrens GMP, LLC. If needed, provide support in cGMP manufacturing.
• Bachelors degree in Biological Sciences, Chemical Engineering or Bioprocessing or related field required.
• MS or Ph.D. preferred.
• Eight (8) years of related experience with a BS.
• Four (4) years of related experience with a MS.
• No related experience required with a Ph.D.
• Experience in process development in a cGMP environment is preferred.