* Manufactures clinical and commercial biologics meeting the regulatory requirements of both domestic and international markets
* Experts and Qualified Trainers in the operation of production equipment in multiple areas in a large scale, automated bioprocess plant such as, bioreactors, centrifuges, virus filtration, depth filtration, tangential flow filtration, chromatography equipment, washers, autoclaves, biological safety cabinets, chemical fume hoods, column packing equipment, and instrumentation pH, conductivity, osmolality, blood gas analyzers, turbidity, etc.
* Accurately analyzes and processes scientific data
* Serves as the "Subject Matter Expert" in unit operation
* Reviews Master Production Records for accuracy and completion of process steps, as requested
* Authors and edits Standard Operating Procedures (SOPs), Master Production Records and Solution Preparation Records
* Responsible for training junior staff
* Mentors others in process operations and domestic and international regulatory compliance
* Routinely monitors manufacturing processes and recognizes potential process issues as they arise; proactively escalates identified issues to senior staff
* Troubleshoots problems and recommends potential solutions to Manufacturing support groups and/or Management
* Contributes to the development of new concepts and techniques
* Leads unit operations or projects, as requested
* Participates in the tech transfer process of new products into the manufacturing area.
* May be cross-trained in multiple areas within Manufacturing
* Identifies and supports the implementation of process efficiencies and areas for improvement