Purpose

AbbVie’s Product Development Science & Technology (PDS&T) organization is seeking a highly motivated, talented, and creative scientist with experience and expertise in solid state and materials characterization for a Principal Research Scientist I position. This person will make key contributions to late-stage product development and commercialization, collaborating with cross-functional teams to deliver robust isolation processes with well-defined control strategies. The ideal candidate should possess an advanced degree in pharmaceutical sciences, chemistry, or chemical engineering with a strong understanding of crystallography, polymorphism, crystallization, isolation process, and materials characterization in the context of commercial product development.

Responsibilities

• Independently plan, execute, and document experiments to characterize the solid-state properties of regulatory starting materials and isolated intermediates following the selection of commercial synthetic routes, to develop robust control strategies.
• Collaborate with solid-state and materials scientists in R&D to identify and mitigate attributes of the drug substance that impact the performance characteristics of the drug product, ensuring robust drug substance control strategies.
•  Provide leadership within a matrixed team environment by serving as a subject matter expert (SME) in polymorphism, crystallography, and material attributes; collaborate with various cross-functional stakeholders and support AbbVie’s manufacturing strategies.
• Author and/or review technical reports, manufacturing batch records, and regulatory documents pertaining to Chemistry, Manufacturing, and Control (CMC) topics. Prepare and deliver concise scientific presentations and publications both within and outside of AbbVie.
• Potentially mentor or supervise a team of one or more individuals, evaluate their performance, and be accountable for their effective performance. Build strong relationships and collaboratively drive activities with other functional units.
• Generate new scientific proposals and lead these efforts. Anticipate and critically evaluate scientific or regulatory advances and competitive threats and respond with appropriate new strategies.
• Ensure compliance with all applicable AbbVie policies and procedures.
• Understand and adhere to corporate standards regarding code of conduct, safety, and GxP. compliance.

Preferred Qualifications

•  Fundamental understanding of polymorphism, crystallography, crystallization, and materials characterization as they pertain to late-stage product development and commercial manufacturing.
•  Experience with analytical methods for characterizing the solid-state and material properties of synthetic molecules and excipients (e.g., DSC, TGA, PXRD, spectroscopy, etc.).
•  Familiarity with software platforms used for visualizing crystal structures and evaluating packing modes, particle shape, surface properties, and other related attributes.
•  Demonstrated scientific communication and presentation skills, with proven success as an author of publications, presentations, and/or as the primary inventor of patents.
• Strong interpersonal and communication skills to facilitate collaborations, with a demonstrated ability to work within or lead cross-functional process development teams.
•  Demonstrated creative, ‘out-of-the-box’ thinking to solve complex technical problems and champion new technologies to achieve project goals.