Sr. Scientist

Position Description- Scientist Senior (Contingent) - Extractable and Leachable

The Senior Scientist will work within a team focused on the chemical characterization of medical devices in a highly regulated environment. The position will report to the chemistry manager. The position is a hands-on and laboratory focused, entailing all aspects of chemical characterization from sample receipt to data reporting. A high level of skill related to sample preparation. method development, and chromatography/mass spectrometry data analysis is required.

Primary Responsibilities

• • Sample preparation (solid/liquid, liquid/liquid extraction, concentration)
  • Extraction solvent / Device material compatibility assessment
  • Leachable study design
  • Establish and communicate timelines
  • Operation of analytical balance, incubator/shaker, ovens, pH meters, and microscopes
  • Analysis with little oversight will include GC/MS, LC/MS, ICP-MS, and FTIR
  • Analytical method development, method enhancements, method qualification
  • Chemical/Material database population and maintenance
  • Training of lab personnel
  • May supervisor or direct others day to day work
  • Data Review/Data Approval
  • Protocol and Report Writing
  • Execution and documentation of work adhering to good laboratory practices (GLP), and Good Manufacturing Practices (GMP)
  • Document, analyze, report, and review data in electronic lab notebook system
  • Adhere to all lab safety requirements

Basic Qualifications:

• BA or BS in chemistry with 8 years of experience/MS with 4 years of experience/PhD with 2 years of experience
• Expert in Extractable and Leachable analysis
• Strong Knowledge of ISO 10993 Part 18
• Ability to perform standard mathematic/statistical calculations in Microsoft Excel
• Strong verbal and written communication skills
• Ability to communicate effectively with chemistry team and management
• Knowledge and application of GDP, GLP, and GMP
• Ability to work autonomously with little oversight of day to day work
• Knowledge and application of Microsoft suite of applications
• Expert with at least one of the following software applications:
  • Chemstation (Open Lab)/ Mass hunter, Empower, Chromeleon, Xcalibur, Tracefinder, Compound Discoverer, Mass Profiler
• Solid experience with mass spectral interpretation GC/MS or LC/MS
• Troubleshooting experience with systems referred to in primary responsibilities section
• Method development and method validation experience
• DOE/statistical analysis as applied to problem solving
• Medical device background

Desired/Preferred Qualifications:

Experience operating Thermo ICP/MS and Agilent GC/MS systems. Experience with ThermoFisher Vanquish/Orbitrap LC/MS systems. Experience with Compound discoverer software. Experience with ACD labs software. Experience with Mass Profiler software

Working Conditions:

• Working in lab environment with proper safety equipment.
• Working with common laboratory chemicals and biological tissue.
• Working while sitting and /or standing.

Physical Demands: Sitting, standing, lifting, carrying, etc.

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