Scientist, Manufacturing Science and Technology, Purification

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.