Analytical Extractable and Leachable Scientist

Job Description

Analytical Scientist (Extractables and Leachable)

Responsibilities

• Work on migration studies, extractable & leachable, impurity isolation, identification, and structural characterization studies
• Perform separation sciences (HPLC and GC) including LC-MS/MS and GC-MS
• Sample preparation skills (liquid-liquid extraction, solid phase extraction) are required
• Work in a GMP analytical laboratory involved with FDA testing (food packaging and pharmaceuticals)
• Review data for technical content and regulatory compliance
• Interact with clients to design scientifically sound studies
• Maintain current expertise with all appropriate ICH, GMP, and FDA guidelines
• Coordinate the timely and compliant generation of data to support client projects

Requirements Educational Qualifications

• B.S. to Ph.D. in chemistry or related field with 2+ years analytical laboratory experience or equivalent combination of education and experience is required. Relevant experience with good manufacturing practices (GMP) is required.

Specific Skills and Requirements

• Experience with HPLC, GC, HPLC-MS/MS, GCMS, semi-prep chromatography, lyophilization, etc.
• Experience with isolation and identification of impurities
• Experience with FTIR and NMR desirable, but not required
• Experience with lab procedures (extraction, solid phase extraction, dilution, etc.)
• Be proficient in Microsoft Excel, Word, and PowerPoint
• Must have basic knowledge chemicals their properties, structure, reactivity, and be able to handle them with safe and appropriate techniques.
• Must be able to communicate effectively with coworkers and have good writing skills
• Must be able to effectively multitask