Scientist, Manufacturing Science and Technology, Purification

BeiGene•Hopewell, VA

19h

About The Position

The Scientist, Manufacturing Science and Technology (MST), Purification is a critical member of the MST Purification person-in-plant and laboratory function. The role specifies and supports downstream unit operations, including chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill, and long-term frozen storage. It monitors and reports on large-scale processes, troubleshoots operations, supports laboratory experiment design and execution, analyzes data, and authors reports. The position supports process improvements, compliance activities, and technical support for Drug Substance manufacturing, with process monitoring and trend analysis as key activities. The role contributes to technology transfer throughout project lifecycles by developing technical transfer plans, conducting gap and risk assessments, preparing process descriptions and control strategies, authoring related protocols and reports, and supporting continuous process verification. It works closely with Drug Substance Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development, and MST colleagues at other sites and in other countries. The position reports directly to the Director, Manufacturing Science and Technology (MST) Purification at the Hopewell, New Jersey site.

Requirements

Bachelor's degree in chemical engineering, biochemistry, biotechnology, biology, or a related discipline.
At least 2 years of relevant experience in the life sciences or biotechnology industry.
Knowledge of monoclonal antibody facilities and process design and development.
Knowledge of biopharmaceutical equipment qualification and validation activities.
Purification knowledge, including chromatography and filtration operations, viral clearance concepts, and drug substance stability.
Familiarity with stainless-steel large-scale equipment and single-use systems.
Ability to analyze data, detect inconsistencies, determine relative importance, conduct root cause analysis, and manage risk.
Experience with technology transfer to or from clinical or commercial manufacturing facilities.
Knowledge of DOE study design and experience authoring study protocols and reports.
Planning and data analysis skills, including statistical software analysis.
Project management skills involving internal and external teams.
Knowledge of cGMP regulations and FDA, EMA, ICH, and PDA guidelines.
Demonstrated experience working in a purification laboratory or manufacturing.
Knowledge of preclinical, clinical, and commercial requirements.
Familiarity with FDA and EMA regulatory requirements for submissions.
Effective oral and written communication skills in a multidisciplinary, project-driven work environment.
Experience with Microsoft Office and JMP or other statistical software.
Ability to work scheduled 40 hours and overtime as needed.
Comfort working in varying temperatures and ability to gown and work in manufacturing areas when required.
Ability to work nights or weekends intermittently as projects progress.
Ability to reach above shoulder level, bend or stoop, push or pull, handle or grip frequently, and perform repetitive hand, wrist, and finger movements.

Nice To Haves

Previous experience with chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill, or long-term frozen storage.

Responsibilities

Specify and support downstream unit operations, including chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill, and long-term frozen storage.
Monitor large-scale processes, report process data, and troubleshoot operations.
Support the design and execution of laboratory experiments, analyze data, and author reports.
Support process improvements, troubleshooting, compliance-related activities, and Drug Substance manufacturing.
Conduct process monitoring and trend analysis of manufacturing operations.
Support technology transfer throughout project lifecycles by generating technical transfer plans, conducting gap and risk assessments, preparing process descriptions and control strategies, and authoring related protocols and reports.
Support continuous process verification.
Collaborate with Drug Substance Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development, and MST counterparts at other sites and in other countries.