R&D Process Engineering, a part of AbbVie’s Development Sciences organization in Synthetic Molecules CMC (Chemistry, Manufacturing, and Controls), is responsible for designing and developing scalable processes to make drug substances and drug products, including small molecules and antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Responsibilities include synthetic route design, process definition, scale-up, and tech transfer for wide varieties of therapeutics and technologies to meet evolving pipeline demand. The R&D Process Engineering team 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, lipid nanoparticles (LNP’s), 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 Engineers within Process Engineering support pipeline projects through all phases of development. Early in development, engineers focus on establishing an enabling process 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 strategies, and prepare reports to support regulatory filings.
Role Overview
The successful engineering candidate will play a key role in the R&D Process Engineering function. The core deliverable of R&D Process Engineering is to develop robust manufacturing processes and advance innovative technologies using strong engineering fundamentals. Key requirements for this role include a demonstrated capability to model antibody drug conjugate kinetics and mechanisms, experience with drug linker and drug substance process design, development of flow chemistry reactor platforms, including in use for ADC’s, experience with highly potent compound handling, leadership of novel reactor configuration development (e.g., photochemistry, electrochemistry, membrane reactors, etc.), and expertise in computational fluid dynamics to support reactor design and tech transfer. The candidate must have prior reaction development and scale-up experience with demonstrated examples of scale up of ADC processes, including reaction and purification.
The candidate is expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization throughout existing and new modalities in Development Sciences, including small molecules, ADC’s, lipid nano-particles, and toxins. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects in the Drug Substance and Drug product space, take part in a cross-functional team to deliver specific project needs, and take on a leadership role in developing and implementing solutions.
Key Responsibilities: