Scientist, Manufacturing Science and Technology, Purification

BeiGene•Hopewell, NJ

2d•$90,400 - $120,400

About The Position

The Scientist, Manufacturing Science and Technology (MST), Purification is a critical member of the MST Purification person-in-plant and laboratory teams. 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. Responsibilities include monitoring manufacturing-scale processes, reporting process data, troubleshooting operations, supporting laboratory experiments and data analysis, and authoring reports. The position supports process improvements, troubleshooting, compliance activities, and technical support for Drug Substance manufacturing. Process monitoring and trend analysis are key activities. The Scientist also participates in technology transfer throughout project lifecycles, developing technical transfer plans, performing gap and risk assessments, preparing process descriptions and control strategies, authoring protocols and reports, and supporting continuous process verification. The role collaborates 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. It 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 operations, 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 perform risk management.
Experience with technology transfer to or from clinical or commercial manufacturing facilities.
Knowledge of DOE study design and 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 environment.
Knowledge of preclinical, clinical, and commercial requirements.
Familiarity with FDA and EMA regulatory requirements for submissions.
Effective oral and written communication in a multidisciplinary, project-driven work environment.
Experience with Microsoft Office and JMP or other statistical software.
Ability to work scheduled 40-hour weeks and overtime as needed.
Ability to work nights or weekends intermittently as projects progress.
Ability to reach above shoulder level, bend or stoop, push or pull, and handle or grip frequently; perform repetitive wrist, hand, and finger motions; and undertake substantial movement.
Comfort working in varying temperatures, gowning and working in manufacturing areas when required, and working with potentially hazardous materials and chemicals.

Nice To Haves

Previous experience supporting downstream unit operations such as chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill, and 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 manufacturing-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.
Monitor manufacturing operations and perform process trend analysis.
Support technology transfer throughout project lifecycles by generating technical transfer plans; performing gap and risk assessments; preparing process descriptions and control strategies; authoring related protocols and reports; and supporting continuous process verification.
Collaborate with Drug Substance Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development, and MST colleagues at other sites and in other countries.