Purification Scientist, Biotech Downstream & Process Tech

BeOne Medicines USA; Hopewell (VA); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

BeOne Medicines USA seeks a Scientist, Manufacturing Science and Technology, Purification, to lead purification operations including chromatography and filtration, monitor at-scale processes, and report process data. The role involves collaboration with Drug Substance Manufacturing, Quality, Regulatory, and Supply Chain teams at the Hopewell site.

The ideal candidate has a BA/BS in a related field, 2+ years in life sciences, and hands-on experience with purification equipment, DOE studies, and

Formación

• BA/BS in chemical engineering, biochemistry, biotechnology, biology or related field.
• 2+ years in life sciences/biotechnology industry.
• Monoclonal antibody facilities knowledge and process design.
• purification knowledge incl. chromatography, filtration, viral clearance and stability.
• Familiarity with large-scale stainless-steel and single-use systems.
• DOE study design and study protocol/report authoring.
• Data analysis and root-cause/risk assessment experience.
• Experience with technology transfer to/from clinical/commercial facilities.
• Regulatory knowledge (FDA/EMA/ICH/PDA) and cGMP literacy.
• Proficient in MS Office and statistical software.

Responsabilidades

• Monitor at-scale processes and report data; troubleshoot operations.
• Support design and execution of lab experiments and data analysis.
• Coordinate technology transfer and validation activities.
• Collaborate with Drug Substance Manufacturing, QA, Regulatory and other groups.
• Assist in process improvements and continuous verification.

Conocimientos

Process data analysis

Data trend analysis

Root cause analysis

Project management

Communication

DOE study design

Technician collaboration

Microsoft Office

JMP

Educación

BA/BS in chemical engineering, biochemistry, biotechnology, biology

Herramientas

Microsoft Office

JMP

Descripción del empleo

BeOne Medicines USA seeks a Scientist, Manufacturing Science and Technology, Purification, to lead purification operations including chromatography and filtration, monitor at-scale processes, and report process data. The role involves collaboration with Drug Substance Manufacturing, Quality, Regulatory, and Supply Chain teams at the Hopewell site.

The ideal candidate has a BA/BS in a related field, 2+ years in life sciences, and hands-on experience with purification equipment, DOE studies, and