Downstream Purification Scientist – Tech Transfer & GMP

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

Descripción de la vacante

BeOne Medicines Ltd. is seeking a Scientist in Manufacturing Science and Technology, Purification, to support downstream unit operations and process transfer.

The role focuses on chromatography, filtration, viral inactivation, and unit operations while coordinating with cross-functional teams in an FDA/EMA-regulated environment. Applicants should have 2+ years in biotech, a relevant BA/BS, and strong data analysis, DOE design, and project management skills.

Formación

• BA/BS in chemical engineering, biochemistry, biotechnology, biology or related discipline.
• 2+ years of experience in life sciences/biotechnology industry.
• Knowledge of monoclonal antibody facilities and process design and development.
• Knowledge of biopharmaceutical equipment qualification and validation activities.
• Purification knowledge including chromatography operations, filtration operation, viral clearance concepts, and drug substance stability.
• Familiarity with stainless-steel large-scale equipment and single-use systems; data analysis and root-cause analysis skills.
• Experience with technology transfer to/from clinical/commercial manufacturing facilities.
• Knowledge of DOE study design and reports.
• Proven planning and data analysis skills; statistical software experience.
• Project management skills for internal/external teams.
• Knowledge of cGMP FDA/EMA/ICH/PDA guidelines.
• Experience in purification lab or manufacturing.
• FDA/EMA regulatory knowledge for submissions.
• Strong written and oral communication in a multi-disciplinary environment.
• Proficiency with Microsoft Office and statistical tools.

Responsabilidades

• Support downstream unit operations including chromatography and filtration.
• Monitor at-scale processes, report data, troubleshoot operations.
• Design and execute lab experiments; analyze data and generate reports.
• Support technology transfer and risk assessments across sites.
• Contribute to process improvements and compliance activities.

Conocimientos

Chromatography

Filtration

Viral clearance

DOE study design

Data analysis

Root cause analysis

Project management

FDA/EMA regulations

Microsoft Office

JMP

Educación

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

Herramientas

JMP

Microsoft Office

Descripción del empleo

BeOne Medicines Ltd. is seeking a Scientist in Manufacturing Science and Technology, Purification, to support downstream unit operations and process transfer.

The role focuses on chromatography, filtration, viral inactivation, and unit operations while coordinating with cross-functional teams in an FDA/EMA-regulated environment. Applicants should have 2+ years in biotech, a relevant BA/BS, and strong data analysis, DOE design, and project management skills.