USA-Laboratory Analyst II (Scientific)

USA-Laboratory Analyst II (Scientific)#26-11077

Framingham, MA

All On-site

Job Description

Description:

The Impurities and potency assay development group in Bioanalytics 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 Bioanalytics team supporting sample testing for a host cell protein ELISA assay.

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. 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.