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Sr. Scientist

Maplewood, MN 55117

Posted: 01/29/2025 Employment Type: Contract Job Category: Scientific Job Number: 617333 Is job remote?: No Country: United States

Job Description

The position has responsibility for project-based MS data processing, accurate compound identification, quantification of unknowns and target compounds, sample preparation, and operation of MS instrumentation (LC and GC and ICP). The role functions as part of an analytical chemistry team following guidelines from ISO10993, GDP and GLP requirements in the medical device industry.

-    Position Responsibilities
o    Partner with biocompatibility customers to determine testing needs and suggest testing strategies
o    Perform E&L method development and analysis (LCMS, GC/MS, ICP/MS)
o    Perform sample preparation techniques (SPE, liquid extractions, concentration, etc)
o    Conduct design of experiments
o    Act as SME for external E&L studies to be a liaison to the CRO’s and biocompatibility team for study design
o    Experience in statistical data analysis (Excel, Minitab, and JMP)
o    Experience in protocol and report writing along with scientific data review
o    SOP, Work Instruction and quality document writing

-    Method Validation Guidelines SME
-    LCMS or GC/MS SME
o    Perform pharmaceutical E&L study design, data collection and analysis (USP 1663 and 1664)
o    Perform medical device E&L study design, data collection, material assessment and analysis (ISO10993)
o    Operate and maintain triple quad LCMS and orbitrap LCMS systems
o    Operate and maintain GC/MS and ICP/MS systems
o    Analyze data with multiple software platforms
o    Ability to review, interpret and approve data

Basic Qualifications
-    Bachelor’s, Master’s, or PhD degree in Chemistry, Biology, Material Science, or related technical discipline
-    Minimum of 5 years of experience performing LC/MS or GC/MS analytical testing (prefer High resolutions MS)
-    Extensive knowledge and experience performing LC/MS or GC/MS separations and identification of unknowns and target compounds in the areas of extractables/leachable, materials, and polymer characterization
-    Ability to collaborate and work as a team player
-    Experience and understanding of cGMP, ISO 10993 part 18, FDA and ICH requirements
-    Ability to work and be effective with minimal supervision
-    Strong verbal and written communication skills
-    Ability to prioritize and execute on daily project tasks
-    Use of Microsoft Excel, Word and Power Point

Desired/Preferred Qualifications
Successful candidate will have experience with Triple Quad and Orbitrap LC/MS instrumentation, with extensive experience in small molecule LC/MS data analysis and unknown identification and quantification. In addition, this person should have a good understanding and experience in either GC/MS or ICP/MS analysis. The candidate will have experience partnering with clients, defining study plans, and leading problem solving initiatives. Additionally, candidates will have experience in a dynamic team environment, strong interpersonal skills, and a strong ability to understand MS concepts related to laboratory data interpretation. Knowledge of medical devices is preferred. The candidate will have excellent organizational and multi-tasking skills that are results oriented. The candidate will also have experience with documenting experiments in a highly regulated environment and knowledge of technical concepts and principals underlying Organic and Inorganic analytical chemistry techniques.
Ideal candidate will be familiar with 1 or more Thermo Scientific software platforms such as Tracefinder, Excalibur and Compound Discoverer for LC/MS, Agilent Mass Hunter and Thermo’s Chromeleon software for GC/MS and Thermo’s Qtegra software for ICP/MS
Familiarity with FTIR, Raman and SEM would be a plus.

?Working w/ Medical Technology and Software background. Must be very familiar with all Cell Dyn systems to set up the systems, collect data and analyze the collected data. Must also be familiar with blood cell morphology to be able to collect reference data. Must be able to conduct experiments with minimum supervision to develop CDX Cal/Con. Must be able to analyze RBC Morphology data using the 3D surface analysis software program (software knowledge in addition to medical technology and Cell Dyn systems knowledge required). Must have a good understanding in clinical applications of Cell Dyn methods.

This position is NonExempt. Hours over 40 will be paid at Time and a Half.

Pay ranges between $35-43.55/hr based on experience 
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About Maplewood, MN

Ready to embark on an exciting career journey in Maplewood, Minnesota? Discover a range of job opportunities waiting for you in this vibrant city just east of St. Paul. Maplewood offers a unique blend of urban amenities and natural beauty, with parks such as Battle Creek Regional Park and Maplewood Nature Center providing a peaceful retreat from the hustle and bustle. Explore the local art scene at South St. Paul Artists' Gallery, catch a show at Merrill Community Arts Center, or cheer on the Minnesota Wild at the nearby Xcel Energy Center. With a thriving community, delectable cuisine options, and a rich cultural tapestry, Maplewood is the perfect place to grow both personally and professionally. Start your job search today and make Maplewood your home for success!

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