Website AbbVie
AbbVie
Company : AbbVie
Job Description
Process Engineering, a part of AbbVie R&D’s Development Sciences organization, is responsible for designing and developing scalable processes to make drug substances and drug products, including small molecules, peptides, and antibody drug conjugates (ADCs), throughout pre-clinical and clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) 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 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 strategy, 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. The ideal candidate will have prior peptide development experience and a passion for hands-on laboratory process 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 take part in a cross-functional team to deliver specific project needs.
Key Responsibilities:
Develop robust manufacturing processes, supporting peptide assets through all phases of development.
Participate in development and characterization of new peptide assets.
Establish, communicate, and execute research plans.
Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
Address challenging problems with peptide-relevant reactions, separations, and/or isolations using expertise in reaction kinetics, transport phenomena, and mathematical modeling.
Author and/or review technical documents summarizing process development efforts and contribute to regulatory filings.
Exhibit a collaborative nature in identifying process challenges on a wide range of projects and communicate findings and recommendations effectively by multi-disciplinary interactions with organic chemists, analytical chemists, process development engineers, pilot plant engineers, drug product development scientists, program managers, and regulatory affairs specialists.
Author publications and present at scientific conferences.