Experienced in the use of multichannel pipette, cell work, and bioassay experience is required. Preferred experience in Dot Blot, ELISA, cSDS methods, and/or HPLC/UPLC.
· In a team setting and cGMP environment, perform routine analytical testing in support of release and raw material samples.
· Conducts routine and non-routine testing of materials and product using a variety of equipment and test methods including but not limited to: HPLC testing, protein concentration testing, nephelometry testing, ELISA, cIEF, and SDS-PAGE.
· Prepare data and documentation using calculators and computer software.
· Entry and review of data in a Laboratory Information Management System (LIMS).
· Peer review, evaluate and investigate results from various analyses.
· Participate in special projects such as laboratory equipment validation, analytical method transfers and SOP reviews.
· Assist and train other chemists in everyday laboratory functions.
· Properly dispose of sample preparations and solutions according to safety and environmental procedures
Performs qualitative and quantitative chemical analysis of in-process manufacturing materials.
Coordinates testing responsibilities to ensure QC test support according to the needs of Manufacturing to maintain continuous process flow. Functions as a team member in the QC In Process Lab to provide timely test analysis information on the status of conformance to requirements. Investigates testing abnormalities and implements corrective action. Cross-trains in all testing responsibilities to ensure a fully cross-functional laboratory team environment. Maintains laboratory chemical supplies to ensure an adequate supply and prevent testing delays. Audits documentation, device history records, and test methods for compliance.