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**Job Function: **
Non-Standard
**Job Sub Function: **
Non-Employee
Job Category:
Non-Standard
All Job Posting Locations:
Shanghai, China
Job Description:
Position: Scientist, Clinical Bioanalysis
Job Description
Johnson and Johnson Innovative Medicine (JJIM) Research & Development China is recruiting for an Scientist Bioanalysis, located in Shanghai China. This position is expected to provide bioanalytical support to clinical study teams to implement and execute PK and immunogenicity sample analysis.
Job responsibilities:
- Serve as the point of contact for internal/external parties, providing guidance for clinical bioanalytical sample management.
- Monitor bioanalytical work at CROs. Provide scientific oversight on bioanalytical method development/transfer and sample analysis.
- Assure CROs fully comply with related GLP/GCLP (NMPA/FDA/OECD) and HGRAO regulations.
- Provide support in any regulatory submission and inspection.
- Other duties as assigned.
Qualification:
- Master’s degree in biology, pharmacology, analytical, DMPK or other relevant bio-medical science disciplines.
- Understanding of modern approaches in bioanalysis to support drug development with > 2 years working experience in pharma/biotech/CROs. Experience with clinical trials is preferred.
- Good communication skills in both English and Chinese.
- The ability to work under timelines, and the ability to collaborate within multidisciplinary teams is required.
- Highly self-motivated and innovative mindset in new area.
**Required Skills: **
Preferred Skills:
Collaborating, Detail-Oriented, Drug Discovery Development, EHS Compliance, Execution Focus, Laboratory Experiments, Process Control, Process Hazard Analysis (PHA), Process Oriented, Report Writing, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Technical Writing, Technologically Savvy, Troubleshooting