Senior Scientist, I - Drug Substance Analytical R&D

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie Analytical Research & Development (Analytical R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.  Our scope includes AbbVie's diverse pipeline of innovative small molecule medicines and spans from the selection of Discovery candidate molecules to Late Stage Clinical.  We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.  Careers in AbbVie Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.  We are looking for diverse candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates. 

Position Description: 

For the Senior Scientist I position, we are seeking a highly motivated candidate who can conceive, implement and execute novel scientific research and development. The candidate can independently develop and optimize new methods and techniques to generate reliable and reproducible data in a timely manner, demonstrate broad versatile technical expertise. He/she should possess understanding of core disciplines and support early phase development of New Chemical Entities (NCEs) drug substance in both preclinical and clinical space. He/she will collaborate within the global Analytical R&D organization and with R&D cross-functional partners such as Pre-Clinical Safety (PCS), Process Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC-Regulatory.  

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 and validation, technical transfer packages, and generation of technical data in support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
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