Perform testing to support analytical development, manufacturing process development, process validations.
Accurately record data in a timely manner, including maintenance of detailed records in compliance with applicable Good Manufacturing Practice (GMP), safety, and environmental requirements. Ensure data integrity and protocol compliance.
Troubleshoot, and execute experiments independently. Analyze data, interpret results, and report data in laboratory notebooks. Collaborate with client to troubleshoot assay problems as they occur.
Support regulatory filings, including INDs and BLAs.
Provide technical support ( ELISA, FRETS, Cell based assays, Flow cytometry & other techniques) with development and QC laboratories and support Quality Assurance.
Ability to handle and maintain various cell lines following aseptic techniques in GMP labs.