Title: Scientist II - Biocompatibility-Chemistry E&LDuration: 12 monthsLocation: St. Paul, MN 55117Position Summary:The scientist will be responsible for performing device extractions following protocols, along with non-volatile residue analysis, FTIR and ICP/MS analysis, will support the liquid chromatography/mass spectrometry (LC/MS) and or gas chromatography mass spectrometry GC/MS teams. This person will work under the guidance of Senior level chemists in the organization so support Extractable and Leachable (E&L) analysis and possibly method development support for the Science and Technology analytical chemistry lab located at Little Canada, Woodridge location. The position is responsible for sample preparation, and operation of E&L analytical equipment. The role functions as part of an analytical chemistry team following guidelines from ISO10993, GDP and GLP requirements in the medical device industry.
Background & Context:The role functions as part of an analytical chemistry team following guidelines from ISO10993, GDP and GLP requirements in the medical device industry.
Key Responsibilities:
- Perform bench chemistry testing to support the E&L team following all our organization's SOP's and requirements.
- E&L support for utilizing analytical instrumentation such as FT-IR, ICP, IC, and possibly GC/MS and LC/MS in a high-throughput environment.
- Follow written test method procedures and protocols to execute E&L testing.
- Document, analyze, and report test results using Lab Vantage Electronic Notebook software system.
- Ensure laboratory cleanliness is maintained, and chemical inventory is well stocked and organized.
- Communicate effectively with supervisor and other team members.
- Expand working knowledge of analytical techniques/instrumentation and troubleshooting skills.
- Support senior level scientists with method development and validation of test methods as needed.
- Support senior level scientists with investigational analysis on medical devices and components as needed.
- Follow our organization's Quality Policy by adhering to documented Standard Operating Procedures and work Instructions.
Qualification & Experience:
- The ability to work in a fast-moving environment where priorities frequently change.
- Ability to perform multiple assignments concurrently and meet required deadlines.
- Bachelor's degree in chemistry or closely related with 1-5 years demonstrated experience.
- Experience with routine laboratory/wet chemistry work.
- Ability to operate analytical instrumentation through educational background or relevant industry experience.
- Experience documenting laboratory work in electronic/paper notebook system according to GMP guidelines.
- Working knowledge with MS Office, with emphasis in MS Excel.
- Experience performing data analysis/statistics and writing technical reports.
- Hands-on lab experience executing protocols and/or performing bench top experiments.
- Ability to follow directions/work SOPs and document the experiments being executed.
- Familiarity with operation and maintenance of analytical equipment such as FT-IR, HPLC, GC, ICP and ion chromatography. (not all may apply)
- Experience assisting analytical method validation.
- Experience with Extractable and Leachable experimentation.
- Minimum of 2-3 years of working within a full functioning lab.
- Candidate must have the ability to collaborate and work as a team player.
- Ability to work and be effective with minimal supervision.
- Strong verbal and written communication skills.