About the job
As a vital component of AbbVie R&D's Development Sciences organization, the Process Engineering team is dedicated to the design and advancement of scalable processes for manufacturing drug substances and products, including small molecules, peptides, and antibody-drug conjugates (ADCs) throughout both pre-clinical and clinical development phases. Our team collaborates closely with the Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions, providing essential engineering support to ensure efficient process scale-up and production of biologics, including toxins and cosmetic active ingredients (CAIs). We are at the forefront of pioneering engineering technologies and generating significant intellectual property through innovative chemical processes and methodologies that lead to cost-effective commercial manufacturing solutions. Our contributions are instrumental in developing the supply chain for our pipeline molecules and in preparing and defending CMC regulatory submissions.
Role Overview
The successful candidate will play a pivotal role within the R&D Process Engineering division. The primary goal is to create robust manufacturing processes and drive the advancement of innovative technologies grounded in solid engineering principles. We are seeking an individual who thrives in hands-on laboratory process development and is eager to identify and cultivate novel approaches and technologies that enhance process efficiency and commercialization. The candidate must possess a collaborative spirit, adeptly addressing process challenges across a diverse array of projects while engaging in cross-functional teams to meet specific project requirements.
Key Responsibilities:
- Engineer and refine robust manufacturing processes, supporting assets through all development phases.
- Engage in the development and characterization of new assets.
- Establish, communicate, and implement comprehensive research plans.
- Design commercial-ready manufacturing processes in the laboratory and demonstrate these processes in the pilot plant.
- Resolve complex issues related to reactions, separations, and isolations by leveraging expertise in reaction kinetics, transport phenomena, and mathematical modeling.
- Prepare reports and documentation to support regulatory filings.