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Analyst, Analytical Development
3 months ago
Required
- ANTIBODIES
- HPLC
- ELISA
- ANALYTICAL CHEMISTRY
- BIOCHEMISTRY
Additional
- ADC
- BIOTECHNOLOGY
- FDA
- TIME MANAGEMENT
- LEARNING AND DEVELOPMENT
- CMC
- MONOCLONAL
- SAMPLE PREPARATION
- PROCESS DEVELOPMENT
- PROBLEM-SOLVING
- PROBLEM SOLVING
- OFFICE SKILLS
- MICROSOFT OFFICE
- SEC
- EXCEL
- SOP
- MICROSOFT POWERPOINT
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
12 months
Max PR: 40-45/hr
Job Title: Analyst, Analytical Development
Onsite: Hopewell Site
Department: Analytical Development
Reports To: Manager - US Site
Full-Time Hours: 40 hours/week
OT: Over-Time may be required on occasion
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 CMC process of biologics drugs, and operation specification for QC and QA.
- Understand the quality requirement of biologics drugs application, cooperate with the application to the complete the experiments or reports.
- Support sample preparation, reagent management, stable sample management.
SKILLS
Core Competencies, Knowledge, and Skill Requirements
- Working experience in an FDA-regulated biotechnology, pharmaceutical company are 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 of time
Significant Contacts: Interacts with all levels of employees.
EDUCATION
Minimum/at least 2+ years working experience with a bachelors or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline.
