Senior Research Engineer-Cell Culture Process Development
Senior Research Engineer - Cell Culture Process Development group is responsible for leading projects supporting the development and optimization of mammalian cell culture processes for recombinant therapeutic proteins utilizing small-scale bioreactor models. This includes process control strategy development, process scale-up and technology transfer to pilot plant and/or manufacturing sites. Responsibility for supporting regulatory filings, leading/supporting organizational strategic initiatives, evaluating and/or installing new capabilities/technologies and leveraging internal and external influence to solve problems and benchmark potential solutions.
Lead the design, execution and interpretation of cell culture process development experiments to drive the definition and optimization of upstream processes for the generation of recombinant protein active pharmaceutical ingredients.
Use first principles and design of experiments (DoE) to predict/understand/control the impact of cell culture process parameters on recombinant protein product quality utilizing small-scale bioreactor models.
Support transfer of upstream processes to TS/MS labs as well as pilot plant and/or manufacturing sites.
Coach, train and lead others in the design, execution and interpretation of experiments to drive the definition and optimization of production processes
Keep abreast of relevant scientific literature, new technologies and regulatory requirements.
Support regulatory filings (e.g. Information Requests, Pre-Approval Inspections, etc.)