**General Description** : This position reports to the Director of Manufacturing Sciences & Technology (Purification). MST Purification is focused of technology transfer activities, including scale-up and scale-down of processes from other internal or external groups. The activities consist of laboratory-scale work and support of manufacturing scale operations. An understanding of chromatography separations, solution make-up, depth, normal, virus, and tangential flow filtration is important in this role. The position will be responsible for design and execution of laboratory experiments, data analysis and authoring of various protocols and reports. Also, the position will support technology transfers for large-scale manufacturing operations, process improvements, troubleshooting, compliance related activities, and provide technical support to manufacturing. The position will be involved with tech transfer activities through the lifecycle of a project, including gap and risk assessments, generating technical transfer plans, process descriptions and control strategies, and related protocols and reports. Working in MST provides a unique growth opportunity for professional exposure to many facets of process development and drug substance manufacturing. This position involves close collaboration with Manufacturing, Supply Chain, Procurement, Quality Control, Quality Assurance, Regulatory, and Process Development groups.  In addition, as the BeiGene Hopewell progresses through initial start-up, process qualification, to becoming fully operational, it provides unique opportunities and challenges to anyone who is looking for career advancement. **Essential Job Functions** : + Participate in cross-functional projects teams that provide tech support to manufacturing and process development, and able to present data and study findings in coherent manner. + Ensure a safe working environment. + Responsible for execution of laboratory experiments and maintaining support laboratory activities. + Authoring of study protocols and reports, and other documentation supporting deviations and regulatory activities. + Perform tech transfer activities, including facility gap and risk assessments. + Provide technical support as SME for implementation of purification processes. + Author technical transfer plans, process descriptions, control strategies, and campaign summary reports. + Perform Continued Process Verification (CPV) and process monitoring during campaigns. + Effective communication with team members and stakeholders. + Serve as Person-In-Plant (PIP) during critical steps of the manufacturing process. + Perform manufacturing data analysis. + Participate in and support on-site supervision and management of contract employees or third parties. + Any other assignment as is determined by the manager. **Qualifications:** + Minimum of 2+ years of experience in the Life Science/Biotechnology after bachelor’s degree, 0+ years after master’s degree). + Demonstrated experience working in purification laboratory or cGMP manufacturing. + Knowledge of drug preclinical, clinical, and commercial requirements. + Familiarity with FDA regulatory requirements for submissions. + Effective communication, oral and written, in a multi-disciplinary, project-driven work environment.  + Computer-savvy. + Keen interest in being part of bringing life-saving drugs to the market. + Knowledge of chromatography for protein separations, tangential flow filtration, analytical equipment for therapeutic proteins. + Ability and aptitude for analyzing data, detecting inconsistencies, determining relative importance, and utilizing data and risk analysis tools. + Experience with downstream process design, optimization, and tech transfer to clinical/commercial manufacturing facilities. + Experience with statistical experimental design (DOE) and authoring of study protocols / reports. + Good understanding of GMP requirements. + Proven planning and data analysis skills, use of statistical software to analyze data + Project management skills related to internal and external teams + Knowledge of regulations and guidelines of FDA, EMA, ICH, PDA. **Physical Requirements** : + Able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently. + Able to work scheduled 40 hours with the ability to work overtime as needed. + 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 hazardous materials and chemicals. + Willing to work off shift, when required. **Supervisory Responsibilities** : + N/A **Computer Skills:** + MS Office, JMP **Other Qualifications:** + N/A **Travel:** + Some travel may occur as a result of duties assigned to the role 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.