What are the responsibilities and job description for the Senior Analytical Scientist position at BeiGene?
General Description
This role presents an excellent opportunity to establish a new analytical lab and oversee the transfer of advanced analytical test methods for late phase clinical/commercial products as a senior analytical scientist in BeiGene's Manufacturing Science and Technology team (MST) located in Hopewell, NJ. The senior scientist will be responsible for managing equipment installation qualification (IOQ), designing, executing, and documenting comparability tests for analytical methods. Additionally, the position involves testing small-scale samples from MST's upstream and downstream sections using transferred analytical methods.
Essential Functions:
- Planning, implementing, and reporting technical transfers for physiochemistry and biochemistry methods (utilizing LC, ELISA, CE, and qPCR).
- Preparing documents such as test methods, test records, standard operation procedures, protocols, and reports.
- Managing analytical equipment from installation and operation qualification (IOQ) to periodical preventive maintenance (PM).
- Cross-functional collaboration with production, QC, QA, Engineering, procurement, and supply chain teams.
- Able to work effectively with stakeholders at other sites across different time zones.
Requirements:
- Masters degree with 2 years of experience or Bachelors degree with 4 years of experience.
- Experience in quality, regulations, and compendial methods.
- Familiarity with technical transfers for non-GMP or GMP production.
- Understanding of physiochemistry and biochemistry analysis for monoclonal antibodies in terms of Process Analytical Technologies (PAT).
- Excellent communication skills and ability to collaborate in cross-functional teams across various geographic locations and time zones.
- Solid understanding of Good Manufacturing Practice (GMP) and data integrity.
- Strong technical writing skills for test methods and technical documents.
- Hands-on experience with physiochemistry, biochemistry tests.
- Beneficial experience in cell-based assays and protein characterization (using LC-MS, CD, SPR).
Computer Skills:
- Waters Empower, JMP, LIMS, Microsoft Office (Word, Excel, PowerPoint, Visio, Project).
Other Requirements:
- 4 years of experience working in quality teams or analytical development teams for biopharmaceutical or biomolecular production-related life science industries.
- Experience working with cross-functional stakeholders and ability to thrive in fast-paced, matrixed environments.
Travel:
Must be willing to travel approximately 10%.
