Upstream Scientist

Title: Scientist I - Upstream/ GMP BiologicsLocation: West Point, PA 19486100% onsiteDuration: 12 months contractShift: Some overtime, including weekends and occasional second and third shift work, will be requiredPosition Summary• Work on pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of biologic and vaccine bulk clinical supplies (focus on cell banks), leading cell expansion unit operations• May contribute to manufacturing activities in bulk upstream/downstream as a support role• Work in matrixed teams with process development, facility engineering, quality engineering, GMP compliance, and safety groups• Assignments include all aspects of preparation, execution, and closeout of a GMP campaignResponsibilities• Executing cell bank manufacturing and upstream unit operations such as mammalian/yeast/bacterial cell expansion, virus/protein expression in single-use disposable systems and/or stainless-steel bioreactors• Secondary role to support downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation• Preparing critical documents including standard operating procedures, batch records• Completing production readiness activities such as equipment cleaning & steam sanitization• Evaluating and integrating innovative technology/process equipment fit• Developing equipment specifications & participating in start-up activities• Working in a multi-disciplinary project team environment• Troubleshooting process unit operations• Leading process unit operation teams• Lead manufacturing steps and plan, communicate, and lead small groups to achieve tactical objectivesEducation:• Bachelor's or Master's degree in Chemical Engineering or Biological Sciences with 1-3 years of relevant experienceExperience:• GMP manufacturing and/or process development cell culture activities (mammalian, bacterial)Skills:• Teamwork and collaboration• Working knowledge of cGMP, Quality Systems, and safety for operations• Self-motivated with the ability to work in a fast-paced and dynamic setting• Organizational, problem-solving, and project management skills• Technical background in cell culture unit operations (vial thaw, shake flasks, cell stacks, flasks, incubation, harvest/centrifugation, vial filling, freeze, thaw/recovery)• Experience leading small teams in a matrixed organization