Senior Scientist II, Technical Operations

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.
• Aid in the 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.

Qualifications

• BS, MS, or PhD in Chemical Engineering or Chemistry with relevant industry experience: 10+ years for BS, 8+ years for MS, 4+ years for PhD.
• Familiarity with modeling and simulation tools such as MATLAB, Python, C++, COMSOL, Scale-Up Suite, or M-Star.
• Experience in process development and strong working knowledge of unit operations commonly used in small molecule synthesis (e.g., reactions, separations, distillation, crystallization, etc).
• Demonstrated experience scaling chemical processes from the laboratory to the pilot plant.
• Solid understanding of fundamental chemical scale-up and process safety principles.
• Preferred 3+ years of experience in pharmaceutical development and/or scaling processes from lab to the pilot scale.
• Experience partnering with EHS for the scale-up of safe processes.
• Advanced understanding of chemical processing engineering principles.