Research Analyst; LBA)

The ideal candidate will be responsible performing lab activities in accordance with applicable Methods, Plans, SOPs/SWPs, GLP regulatory guidelines and 21 CFR Part 11 as directed from Group Leader and Sr. Analysts.

Independently conduct Bio-analysis validation and sample analysis in support of nonclinical and clinical studies.

Conduct Pre-Study with minimal supervision.

Utilize establish techniques to compile and analyze data.

Document work and maintain study documentation and lab records.

Responsibilities

• Understand and comply with GLP requirements and follow Methods, Plans and SOP/SWPs and related lab procedures; comply with safety policies, comply with company policies.
• Use and properly maintain lab instrument and equipment appropriately for assigned tasks.
• Conduct Bio-analysis validation and sample analysis independently meeting company quality standards.
• Conduct pre-study method development with minimal supervision.
• Prepare worksheets.
• Data processing and table preparation (i.e., QC data and preparation, data integration, raw data printing, preparation of chromatograms for the report, use of Watson LIMS, etc.)
• Maintain accurate records of work and study documentation per Good Documentation Practices as per company SOPs.

Qualifications

• Bachelor's degree or equivalent experience
• ELISA – absorbance, fluorescence, luminescence