Senior Scientist

AbbVie is looking for a highly motivated Senior Scientist to drive new technologies and processes. The candidate will develop drug product formulations and scalable manufacturing processes for NBEs used in clinical trials through all phases of development.

Requirements

• BS and typically 10+ years of experience; MS or equivalent education with typically 8+ years of experience; PhD 0+ years of experience in formulation or analytical development of NBEs
• Scientific understanding of the structure & function of monoclonal antibodies and antibody constructs/conjugates, and their modes of degradation/stabilization
• An understanding of scientific approach to develop biologic protein formulations
• Strong lab skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays)
• Basic understanding of unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling and lyophilization for liquid and lyophilized NBEs
• Hands on expertise of bio analytical test methods for protein pharmaceuticals e.g. mass-spectrometry, HPLC and electrophoretic methods, particle imaging, ELISA, compendial tests
• Broad expertise around regulatory requirements for NBEs (mAbs, bispecifics, ADCs) and parenteral products is preferred (21 CFR parts 600 & 210, FDA cGMP-, ICH-, EU GMP-guidances).
• Statistical knowledge and experience is preferred e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies