Job Purpose: Will work in the Cell Culture area to support, process validation and routine manufacturing for the Flu Cell Culture vaccine. The position will directly support manufacturing operations as a technical process expert.
Provide manufacturing support including process mapping, process troubleshooting, process improvement, process management and supporting DoE experiments based on Six-Sigma methodologies.
Support preparation for process scale-up, process transfer and process validation.
Participate in technical risk assessment for process issues and changes.
Assist in technical studies for at-scale and scale-down studies to support new strain introduction and process improvements.
Responsible for full-scale development, validation runs, and ongoing commercial manufacturing runs
Bachelor's degree in engineering or related scientific area.
Desirable: Specialization/training in biotechnology and continuous improvement methodologies is desirable.
Demonstrated 2+ years of successful experience in process development or manufacturing support of biotechnology (cell based) derived vaccines or biopharmaceuticals is required In-depth knowledge and work experience in cell-culture technology area is required.
Experience in technology transfer, scale-up, and GMP operation is required.
Demonstrated laboratory skills and familiarity with purification and/or fill-finish technology areas including associated analytical methods is desirable.
Demonstrated experience in continuous improvement methodologies to support of commercial manufacturing is desirable.
Novartis - 18 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...