Senior Analytical Scientist

Position Overview

The Senior Analytical Scientist is a critical member of the corporate R&D and Quality technology team. Primary responsibilities of the Senior Analytical Scientist include chromatography initiatives, HPLC, gas chromatography, mass spectrometry analysis, NMR analysis, IR analysis, and GPC chromatography. The Scientist will be responsible for all aspects of GMP testing, both internally and with external partners. Setting up new internal testing capabilities will be a key function of the role.

Essential Job Functions

• Qualify, calibrate, and maintain chromatography equipment and other analytical instruments; specifically, HPLC/GC instrumentation
• Develop and maintain analytical test methods, method validation protocols, and prepare drafts of analytical reports complying with guidelines from FDA, USP, or ICH.
• Verify USP / NF or other commonly recognized test methods applicability
• Validation of new HPLC/ GC instrumentation
• Set up/maintain systems for research and quality use
• Purchase and inventory appropriate levels of consumables and replacement parts
• Direct/run samples for R&D, stability, raw materials, and final product testing.
• Develop product specifications.
• Develop and document equipment and activity SOP’s.
• Maintain relevant quality control documents.
• Conduct Product Conformance Investigations (PCI) on products that are believed to be nonconforming or defective.
• Train personnel as required.
• Perform reverse analysis on competitive products or other key samples
• As time permits, develop expertise around key non-chromatographic equipment.
• Organize contract research with outside labs.

Qualifications

• 3-5 years’ experience with MS Degree. 8-10 years’ experience with BS Degree.
• Familiar with lab safety requirements.
• Good interpersonal communication skills
• Ability to supervise, delegate and work well with others
• Understanding and knowledge of cGMP, FDA’s Pharmaceutical GMPs, USP/NF standards, EPA testing and requirements
• Highly organized and detail oriented
• Proficiency in all MS office applications
• Highly organized and detail oriented
Education

• Minimum B.S. in Chemistry
• MS in Chemistry a plus

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