Laboratory Analyst II

Job Description

Job Summary:

• The Impurities and potency assay development group in Bioanalytic develops plate based assays to support monoclonal antibody and enzyme replacement therapy products in Client.
• We are seeking a motivated contract employee to work as a member of the Bioanalytic team supporting sample testing for a host cell protein ELISA assay.

Duties and Responsibilities:

• Perform routine sample testing for a host cell protein ELISA based assay.
• Manage work assignments, analyze and interpret test results, and conduct necessary troubleshooting under the supervision of the manager.
• Successfully train and support sample testing (non-GMP) for Client programs.
• Document the data per department policies in the relevant data packets or Electronic lab notebooks, in a timely manner (GLP documentation).
• Ensure compliance by supporting equipment and lab maintenance on a routine basis.
• Experience working in a QC laboratory a plus.
• Must be able to work collaboratively in a fast paced, team oriented environment.

Experience:

• Must have previous experience developing ELISA or plate based assays and/or testing samples.
• Demonstrated ability to document data in a compliant and timely manner.

Preferred:

• Experience with development and sample testing using Host cell protein/impurity based ELISA assays.
• Experience working in a QC laboratory or GMP environment.
• Proficient in Microsoft Word, Excel, PowerPoint, has utilized plate based software such as SoftMax Pro.
• Must be a team player, organized and efficient and able to work according to timelines.