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.  The ideal candidate will have significant prior reaction development and scale-up experience with demonstrated examples of scale up of small molecules and/or biologics from lab to pilot or production scales.  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, 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

• Develop robust manufacturing processes, supporting assets through all phases of development. 
• Participate in and/or lead project teams towards development and characterization of new small and large molecule assets. Establish, communicate, and execute research plans.
• Develop commercial ready manufacturing processes in the laboratory and demonstrate the processes in the pilot plant.
• Set project strategies, define project responsibilities and timelines, and provide leadership in a matrixed team setting.
• Address challenging problems with chemical and biochemical reactions, separations, and/or isolations using demonstrated expertise in reaction kinetics, transport phenomena, and mathematical modeling.
• Develop and apply process analytical technologies and data-rich experimentation tools to build appropriate reaction and process understanding via model-guided experimentation.
• Build data driven and knowledge driven models to facilitate successful scale-up and tech transfer.
• 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.