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General Description:

This position reports to the Associate Director of Manufacturing Science and Technology (Analytical Development). This role offers an exciting opportunity to lead analytical test method transfers for commercial products as a Analytical Scientist in BeOne Medicine’s Manufacturing Science and Technology (MST) team, located in Hopewell, NJ.

The scientist will perform the design, execution, and documentation of technical transfers and analytical method validations, as well as conduct tests on small-scale samples from the upstream and downstream MST processes using transferred methods.

Also, the analytical method development and optimization will be asked for analytical tech transfer, method improvement, investigation or troubleshooting purpose.

The position requires experience in quality control (QC) or analytical roles within process/analytical development, or analytical method transfer/qualification/validation, particularly in biologics or life sciences companies. Strong experience working with cross-functional teams and a demonstrated ability to thrive in a fast-paced, matrixed environment is essential.

Essential Functions of the Job:

+ Planning, implementing, and reporting technical transfer for physiochemistry and biochemistry methods (using LC, ELISA, CE, qPCR, and etc.).

+ Preparing documents such as test methods, test record, standard operation procedure, protocol, and report.

+ Managing analytical equipment from installation and operation qualification (IOQ) to periodical preventive and maintenance (PM).

+ Cross functional work with manufacturing, QC, and QA.

+ Capability to work with the other site stakeholders in different time zone.

Computer Skills:

+ JMP, Waters Empower, Microsoft Word, Microsoft Excel, SoftMax.

Qualifications:

+ Bachelors’s degree with 2 years of experience

+ Experience and knowledge of quality, regulations, and compendial methods.

+ Strong understanding and experience of technical transfer for non-GMP or GMP production.

+ Understanding physiochemistry and biochemistry analysis for monoclonal antibody in terms of Process Analytical Technologies (PAT).

+ Communication skills and work in cross-functional teams in various geographic locations in different time zones.

+ Solid understanding of Good Manufacturing Practice (GMP) and data integrity.

+ Knowledge and experience on monoclonal antibody manufacturing is required.

+ Excellent technical writing skill in test methods, technical documents.

+ Hands on experience on physiochemistry and biochemistry tests.

+ Experience for cell-based assay and protein characterization are beneficial (using LC-MS, CD, SPR).

**Travel:** up to 10%

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.