Process Engineering, a part of AbbVie R&D’s Small Molecule CMC Development organization, is responsible for designing and developing scalable processes to make small molecule drug substances and drug products, including antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products, including toxins and cosmetic active ingredients (CAIs). We contribute to the development of innovative engineering technologies and create valuable intellectual property through the composition of matter, chemical processes, and technologies resulting in cost-effective commercial manufacturing processes. We support the development of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content.
Chemical/Bio Engineers support pipeline projects through all phases of development. Early in development, engineers focus on ensuring that the process can be run safely, identifying and addressing scale-up issues, enabling processes that can be scaled-up successfully. In the later stages of development, engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work cross-functionally to transfer the optimized process to manufacturing sites, develop control strategy, and prepare reports to support regulatory filings.
Role Overview
The successful candidate will play a key role in the Center of Excellence in Crystalline Drug Substance and Drug Product (CrySP), a part of Process Engineering function. The core deliverable of Process Engineering is to develop robust processes to manufacture small molecule Active Pharmaceutical Ingredients (API), Antibody Drug Conjugates (ADCs), toxins, cosmetic active ingredients (CAIs), and drug products utilizing strong engineering fundamentals. The idea candidate will have background in crystallization fundamentals and crystallization process development. Process Engineering also leads the development of isolation and purification strategies for both small and large molecule compounds. The ideal candidate will have a passion for hands-on laboratory process development and a proven track record in research and development. The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects and participate in a cross-functional teams to deliver against specific project needs.
Key Responsibilities: