Scientist I

The Scientist II sets up Extractables & Leachables studies and conducts quantitative and qualitative analyses according to FDA, cGMP, and Boston Analytical Inc.

Standard Operating Procedures.

include analysis of extract and pharmaceutical product samples using LC-MS, GC-MS, and/or ICP-MS.

A Scientist II will also develop and validate leachables methods for these techniques.

• Prepares and analyzes samples and sample extracts to detect and identify extractables from pharmaceutical packaging and leachables from drug product samples.
• Coordinate findings with team members.
• Maintain and calibrate analytical equipment following established procedures.
• Author detailed cGMP report sections for work performed.
• Develop and validate leachables methods for LC-MS, GC-MS, and/or ICP-MS.
• Train other team members on the various techniques performed in the E&L lab.
• Write, maintain, and edit departmental Standard Operating Procedures.
• Perform peer review of work from other team members.
• Perform assigned tasks and duties independently with minimal supervision.
• Prepares samples for analysis by GC-MS.
• Analysis of sample solutions by liquid injection and headspace GC-MS to adequately resolve and identify all compounds.