Biocompatibility Scientist (ISO 10993/LCMS/HPLC)

Senior Scientist Extractable and Leachable (contingent)

• The senior scientist will be responsible for performing liquid chromatography/mass spectrometry (LC/MS) and or gas chromatography mass spectrometry GC/MS, Extractable and Leachable (E&L) analysis and possibly method development support for the Science and Technology analytical chemistry lab located , Woodridge location.
• 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

• Partner with biocompatibility customers to determine testing needs and suggest testing strategies
• Perform E&L method development and analysis (LCMS, GC/MS, ICP/MS)
• Perform sample preparation techniques (SPE, liquid extractions, concentration, etc)
• Conduct design of experiments
• Act as SME for external E&L studies to be a liaison to the CRO’s and biocompatibility team for study design
• Experience in statistical data analysis (Excel, Minitab, and JMP)
• Experience in protocol and report writing along with scientific data review
• SOP, Work Instruction and quality document writing
• Method Validation Guidelines SME
• LCMS or GC/MS SME
• Perform pharmaceutical E&L study design, data collection and analysis (USP 1663 and 1664)
• Perform medical device E&L study design, data collection, material assessment and analysis (ISO10993)
• Operate and maintain triple quad LCMS and orbitrap LCMS systems
• Operate and maintain GC/MS and ICP/MS systems
• Analyze data with multiple software platforms
• 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.

Job Type: Contract

Pay: $45.00 - $47.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Commuter assistance
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• LC/MS or GC/MS analytical testing: 5 years (Preferred)
• HPLC: 5 years (Preferred)
• method validation: 5 years (Preferred)
• medical device: 5 years (Preferred)
• ISO 10993 part 18, part 12: 2 years (Preferred)

Ability to Commute:

• Saint Paul, MN 55117 (Required)

Work Location: In person

Salary : $45 - $47