Teva Branded Pharmaceuticals Products R&D LLC seeks an Associate Scientist in our West Chester, PA office to: troubleshoot or investigate study results, as applicable and independently author technical reports and prepare data presentations for cross-functional teams with minimal supervision.
Support drafting regulatory filling document (IND, BLA etc). Perform routine cell culture experiments including seed culture expansion, bioreactor operation and clarification activities to support early and late -stage process development.
This includes, but is not limited to experiments in shaker flasks, Ambr15, Ambr 250, 10L, 50L, 100L and 200L bioreactors, disc-stack centrifuge, and filtration.
Perform equipment set-up, sterilization, daily operation, sampling and in-process tests (Ex: cell count, viability, gases, metabolites, titer). Record experiment results in batch records and electronic lab notebooks in compliance to Good Documentation Practices.
Perform data analysis as needed.
Design and conduct experiments to support upstream process development and process characterization activities under managerial supervision.
Develop experimental plan and execute cell culture and/or harvest studies in laboratory either individually or as a part of working team.
Maintain and troubleshoot laboratory equipment, coordinate calibration, and manage raw material stocks and supplies in collaboration with relevant internal groups.
Lead USP projects for timeline driven deliverables in a multi-disciplinary matrix organization.
Approximately 10% domestic travel and 10% international travel required for business purposes including attending conferences and trainings.
Minimum Requirements: Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology or a related field and 2 years of mammalian cell culture and bioreactor operation experience in a biopharmaceutical company.
Must have experience with: Chemical engineering principles; Process-scale up and scale-down model qualification activities; Early and late-stage cell culture development activities; Process characterization activities; Design of experiments (DOE) and statistical modeling; and, Statistical software for data analysis and statistical modeling including JMP and SIMCA.
Please apply at using REQ ID 61694.
Teva Branded Pharmaceuticals Products R&D LLC is an EEO/AA employer.
No calls.