The Process Engineering and API Clinical Supplies (PEACS) organization within AbbVie’s Synthetic Molecule CMC (Chemistry, Manufacturing, and Control) Division in Development Sciences invents synthetic processes to prepare active pharmaceutical ingredients (APIs) to enable the development of AbbVie’s pipeline and supply materials for clinical programs. AbbVie is seeking a highly motivated individual with a proven track record of accomplishment to join the API Pilot Plant Technical Operations (Tech Ops) group. This position will serve as a liaison between the synthetic molecule CMC scientific functions and the API Pilot Plant organization to ensure safe and robust scale up of API manufacturing processes. The successful candidate will assist in the optimization and scale-up of synthetic processes and facilitate the implementation of new technologies in the API Pilot Plant. The Scientist will also provide technical oversight during production campaigns and will support technical transfer to the ultimate commercial manufacturing site. 

Responsibilities: 

• Technical and project management of processes entering the API Pilot Plant, including scheduling, equipment selection, materials tracking, authoring direction sets, obtaining safety analyses, and executing pre-runs. 

• Partner with API project teams to optimize processes for scale-up. Identify appropriate equipment, sizing, and configurations. 

• Technical oversight of processes running in the API Pilot Plant, and responsibility for process-troubleshooting in collaboration with the API project teams. 

• Serves as the primary point of contact between API Pilot Plant, API project teams, Quality Assurance, and Environmental Health and Safety. 

• Build data-driven and knowledge-driven models to facilitate successful scale-up and tech transfer. 

• Identify, evaluate, and implement new technologies for the pilot plant and/or identify opportunities to modify or leverage existing assets to enhance operational efficiency, which strategically align with the long-term goals of the API Pilot Plant.  Examples include automation, flow chemistry, novel separations, Process Analytical Technology (PAT), feedback control, and drying technologies. 

• Support the implementation of PAT. Assist with equipment specification, setup, data collection, and analysis.  

• Support the introduction of new modalities into the plant. 

• Interface with API project teams to ensure that processes are safe, scalable, and operable. 

• Assist with technology transfer of late-stage processes to commercial sites, including process fit, identification of equipment needs, and facility modifications. 

• Responsible for review and documentation of data for cGMP execution of chemical processes. Authors campaign summary reports. 

• Exhibit a collaborative nature in identifying process challenges 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, quality assurance specialists, and regulatory affairs specialists. 

• Author publications and present at scientific conferences.