Senior Scientist

AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs approximately 28,000 people worldwide and markets medicines in more than 170 countries.

Basic:

• 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 

All your information will be kept confidential according to EEO guidelines.