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Analyst, Analytical Development - Hopewell, United States - Snelling Staffing El Paso, Texas
Description
DUTIES:
Perform analytical tests to support process development and transfer analytical methods to QC department.
Essential Functions of the job:
• Write SOP, experimental methods, and reports. Perform routine analytical tests (e.g., SEC, CE, ICIEF, Protein A) to support the upstream and downstream process development.
• Support the development and transfer of analytical methods of biologics drugs (including monoclonal antibodies, bispecific antibodies, ADC).
• Understand the CMC process of biologics drugs, and operation specification for QC and QA.
• Understand the quality requirement of biologics drugs application and cooperate with the application to complete the experiments or reports.
• Support sample preparation, reagent management, and stable sample management.
SKILLS:
Core Competencies, Knowledge, and Skill Requirements
• Working experience in an FDA-regulated biotechnology, or pharmaceutical company is required.
• Proficient in analytical chemistry or biology background, skilled in analyzing biological drug products (monoclonal antibodies, bispecific antibodies, ADCs) analysis methods, including but not limited to HPLC, UPLC, CE, Elisa.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Ability to prioritize, demonstrating good time management skills.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
Computer Skills:
• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Travel:
• Must be willing to travel approximately 10%
• Ability to work on a computer for extended periods
Significant Contacts: Interacts with all levels of BeiGene employees.
EDUCATION
Minimum/at least 2+ years working experience with a bachelor's or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.
Certifications & Licenses: CMC
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