AbbVie Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products.  Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial product launch.  We are a world-class team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVie's pipeline of innovative medicines.  Careers in AbbVie Parenteral PDS&T provide opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science.

The Analytical Development group is responsible for programs that are transitioning from development stage to optimization and commercialization.  We lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories.  Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content.  This position will work primarily inside of the laboratory, providing testing support to meet Analytical Development’s deliverables for pipeline programs.

Key Responsibilities

• Routinely demonstrate scientific initiative and creativity in research and development activities to solve difficult problems and champion new analytical technologies to achieve project goals.
• Perform method development, optimization, and validation for late-stage biologics programs.
• Independently responsible for project activities within area of expertise while also contributing within the project team to the overall progress of the program.
• Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Effectively organize and present scientific plans and data.
• Author technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents.