Scientist, Manufacturing Science and Technology, Purification

BeOne Medicines USA

Hopewell (VA)

In loco

USD 90.000 - 120.000

Tempo pieno

4 giorni fa

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Descrizione del lavoro

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

Competenze

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.

Mansioni

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.

Conoscenze

Process data analysis

Data trend analysis

Root cause analysis

Project management

Communication

DOE study design

Technician collaboration

Microsoft Office

JMP

Formazione

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

Strumenti

Microsoft Office

JMP

Descrizione del lavoro

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This Scientist, Manufacturing Science and Technology, Purification position is a critical role within the MST Purification person-in-plant and MST laboratories specifying and supporting downstream unit operations, such as chromatography, normal and tangential flow filtration, viral inactivation, buffer preparation, drug substance fill and long-term frozen storage. Previous experience with these is preferred. The position will be responsible for monitoring at scale-process, reporting on process data, and troubleshooting operation. The function supports design and execution of laboratory experiments, data analysis and authoring of various reports. This position reports directly to the Director, Manufacturing Science and Technology (MST) Purification at the Hopewell, NJ site.The position will support process improvements, troubleshooting, and compliance related activities and provide technical support to Drug Substance manufacturing. Process monitoring and trend analysis of manufacturing operations will be a key activity required for the position.The position will be involved with technology transfer activities through the lifecycle of a project, generating technical transfer plans, performing gap and risk assessments, process descriptions and control strategies, related protocols and reports, and continuous process verification.Working in MST Purification provides a unique growth opportunity for professional exposure to large-molecule process development and drug substance manufacturing. This position involves close collaboration with Drug Substance Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, Process Development groups and MST counterparts located in other sites and countries. In addition, with advancement in BeOne large-molecule pipeline, unique opportunities and challenges will be presented for career advancement.

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.
Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, conducting root cause analysis, and risk management.
Experience with technology transfer to/from clinical/commercial manufacturing facilities.
Knowledge of DOE study design and authoring of study protocols / reports.
Proven planning and data analysis skills, and statistical software analysis.
Project management skills related to internal and external teams.
Knowledge of cGMP regulations and guidelines of FDA, EMA, ICH, PDA.
Demonstrated experience working in 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 in a multi-disciplinary, project-driven work environment.
Experience with Microsoft Office suite, JMP or other statistical software.

Physical Requirements :

Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
Must be able to work scheduled 40 hours with the ability to work overtime as needed.
Must be comfortable in working in varying temperatures.
Ability to gown and work in manufacturing areas, when required.
Some reaching, bending, stooping, and twisting
Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
Environment requires dedicated gowns, depending on area.
Work with potentially hazardous materials and chemicals.
Expected to work nights or weekend intermittently, as projects progresses.

Global Competencies