Senior Scientist I, Drug Substance Analytical R&D

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

This position will focus primarily on drug substance (active pharmaceutical ingredient) programs in a dynamic environment from pre-clinical through first-in-human clinical stages. The individual will independently create phase-appropriate analytical methods to facilitate process development, assess stability, control manufacturing impurities, and enable release testing of pre-clinical and clinical drug substances. They will work closely with synthetic organic chemists in Process Chemistry to establish appropriate proposed regulatory starting materials, design efficient control strategies, support reaction troubleshooting, and identify manufacturing impurities or degradants. Candidates should be comfortable discussing organic chemistry topics relevant to analytical chemistry, such as stereoisomers, common functional groups, and pKa values. Experience with chromatographic analysis (such as HPLC or GC) is preferred but not required. Experience with analysis of peptides and solid-phase peptide synthesis (SPPS) is preferred but not required.

Responsibilities:

• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical drug substances to further the understanding of emerging non-GMP and cGMP manufacturing processes.
• Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the development pipeline.
• Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule drug substances, intermediates, starting materials, impurities, and impurity profiling.
• Support new product development with advanced method development