Sr. Analytical Scientist

General Description:

This role provides a good opportunity for setting a new analytical lab and engaging analytical test method transfer for late phase clinical phase/commercial products as a senior analytical scientist in BeiGene Manufacturing Science and Technology team (MST) located in Hopewell NJ. The senior scientist will manage equipment IOQ, then design, execute, and document comparability test for analytical method. Also, the test for small scale samples from MST upstream and downstream parts by transferred analytical method. The position requires experience in quality control team or analytical team in process development or similar team in biological pharmaceutical or life science company. The candidate must have experience working with cross-functional stakeholders and demonstrated ability to thrive in a fast-paced, matrixed environment.

Essential Functions of the job:

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

• 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 production, QC, QA, Engineering, procurement, and supply chain.

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

Core Competencies, Knowledge and Skill Requirements

• Master's degree with 2+ years of experience or Bachelor's degree with 4+ years of experience

• Experience of quality, regulations, and compendial methods

• Experience on technical transfer for non-GMP or GMP production

• Understanding of 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

• Excellent technical writing skill in test methods, technical documents

• Hands on experience on physiochemistry, biochemistry tests

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

Computer Skills: Waters Empower, JMP, LIMS, Microsoft Office (Word, Excel, PowerPoint, Visio, Project)

Other Qualifications:

• 4+ years of experience working in quality team or analytical development team for biopharmaceutical or any biomolecular production related life science industries.

• Work experience with cross-functional stakeholders and demonstrated ability to thrive in a fast-paced, matrixed environment.

Travel:

• Must be willing to travel approximately 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.