Purification Scientist, Downstream Process Expert

BeiGene, Ltd.; Hopewell (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

401(k)

Equity awards

Employee stock purchase plan

Wellness program

Job summary

BeOne Medicines Ltd. seeks a Scientist in Manufacturing Science and Technology (Purification) to lead purification operations, develop scalable processes, and support technology transfer from development to manufacturing.

You will work with chromatography, filtration, viral clearance, and GMP-compliant documentation across multiple teams. The role emphasizes data analysis, problem solving, and cross-functional collaboration with Drug Substance Manufacturing, Quality, Regulatory, and other BeOne

Qualifications

• BA/BS in chemical engineering, biochemistry, biotechnology, biology, and/or related discipline.
• 2+ years of relevant experience in life sciences/biotechnology industry is required.
• 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 risk management abilities.
• Experience with technology transfer to/from clinical/commercial manufacturing facilities.
• DOE study design and study/report writing.
• Proven planning and data analysis skills and statistical software usage.
• Project management across internal and external teams.
• Knowledge of cGMP FDA/EMA/ICH/PDA guidelines.
• Experience in purification laboratory or manufacturing.
• Understanding preclinical/clinical/commercial requirements.
• FDA/EMA regulatory submission familiarity.
• Effective oral and written communication in a multidisciplinary team.
• Proficiency with Microsoft Office and JMP or similar tools.

Responsibilities

• Monitor at-scale purification processes and report data.
• Troubleshoot operations and support technology transfer.
• Design and execute laboratory experiments; analyze data.
• Prepare process descriptions, control strategies, and related reports.
• Collaborate with Drug Substance Manufacturing, Quality, Regulatory, and MST counterparts at other sites.

Skills

Data analysis

Root cause analysis

DOE study design

Project management

Regulatory knowledge

cGMP knowledge

Statistical software

Communication skills

Team collaboration

Process development

Education

Chemical engineering degree

Biochemistry/Biotech background

Tools

JMP

Microsoft Office

Job description

BeOne Medicines Ltd. seeks a Scientist in Manufacturing Science and Technology (Purification) to lead purification operations, develop scalable processes, and support technology transfer from development to manufacturing.

You will work with chromatography, filtration, viral clearance, and GMP-compliant documentation across multiple teams. The role emphasizes data analysis, problem solving, and cross-functional collaboration with Drug Substance Manufacturing, Quality, Regulatory, and other BeOne