Provide scientific and technical support to clinical and commercial manufacturing at the Biogen Idec manufacturing site in Cambridge, MA. The candidate will plan, execute, and document laboratory experiments in support of technology transfers, manufacturing changes, and process improvements. Projects will include laboratory scale experiments to support large-scale manufacturing, process investigations, application of process statistical tools, and the introduction of new manufacturing and analytical technologies. This individual will also lead cross-functional technology transfer teams and investigation teams.
- Expertise with mammalian cell culture and bioreactors in a cGMP-manufacturing environment is preferred.
- Experience with downstream purification, analytical techniques, and application of statistical analysis tools to resolve issues or to make improvements, is desired.
- Project management skills, team leadership experience, and excellent written and oral communication skills are required.
- Authoring experience with IND or BLA CMC sections is desirable.
Masters Degree in relevant science or engineering discipline, with 4-8 years of mammalian cell culture and bioreactor experience. Will also consider a PhD in the area of mammalian cell culture and bioreactors with 0-4 years of industry experience.