- Conducts routine and non-routine sample analysis in compliance with GLP, applicable methods, protocols, SOPs, and regulatory agency guidelines.
- Provides input and participates in project meetings.
- Performs QC review of data.
- Reports any difficulties, unexpected findings and/or deviations that may affect the integrity of the data to Study Director/Manager, Principal Investigator/Contributing Scientist and/or management of and participates in corrective action of problems.
- Displays understanding of theory and ability to set up and perform practical requirements for routine and non-routine assays and for the instruments used
- Develops working knowledge to assist in performing validations of various Immunotoxicology assays.
- Maintains awareness and compliance with all safety directives and safety procedures in accordance with the regulations.
- Assist in the preparation and checking of Study Plans/Protocols and analytical reports
- Assist in the preparation of analytical method documentation
- Assist in the preparation and revision of Standard Operating Procedures
- Assist with the generation of tables, graphs, and data sets using specific software and systems.
- Assist with the timely archiving of study documentation and/or related study materials and electronic archiving
- Assist with updating various indexes and logs
- Accepts responsibility in ensuring clean and safe laboratory work environment.
- Support training and assists less experienced staff, prioritize workloads on a daily basis contributing to a team environment and culture of care.
- Ensures that chemicals and reagents in use, are correctly labelled and associated documentation is available.
- Participates in process improvement initiatives.
- Participates in client visits/audits as required.
- Builds competency in a comprehensive range of I&I procedures.
- Develops knowledge to assist in writing text for methods or protocols.
- Fully participate in Performance Management Systems
- Performs other related duties as assigned.
Preferably master degree in immunotoxicology, two or three years working experience in CRO company.
- Knowledge in cell culture, Flow Cytometry, ELISA, Luminex and ELISpot, etc.
- Computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
- Strong organizational skills
- Skilled in conducting research, compiling data and organizing document according to FDA, EMA and NMPA regulatory requirements.
- Strong English writing and communication skills.
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