Scientist LC/GC Data Interpretation, Medical Device

About the role

Client is attempting to get their medical device approved by FDA for market and clinical use. This requires chemical characterization by ISO 10993-18, a service offered by EAG Laboratories. Client sends the devices to EAG. The analytical team extracts the devices in various solvents, analyzes the extracts by LCMS and GCMS (and other techniques), and identifies all peaks (extractables) above a specified reporting limit. The extractables are ultimately assessed by a toxicologist for safety/risk. An individual in this role would be conducting the interpretation (identification) of the LCMS and/or GCMS extractable data. This would be high-throughput, moderate-paced, location-flexible work (primarily on-site, but able to be done remotely, as needed).

Equipment used

Software relevant to LCMS and GCMS data interpretation: Compound Discoverer, Trace Finder, Unknowns Analysis, Mass Hunter.

Responsibilities

• Conduct interpretation (identification) of LCMS and/or GCMS extractable data
• Comply with ISO 27001 standard and company requirements for Information security

Qualifications

• MS degree in Chemistry/related field with 3+ years of industry experience OR PhD in Chemistry/related field with 2+ years of industry experience
• LCMS and/or GCMS data interpretation is required (instrument operation alone is not sufficient)
• LCMS/GCMS and laboratory experience/familiarity with several techniques
• Proficient in Microsoft Office and Excel in particular
• Excellent professional, verbal, and written communication skills
• Excellent attention to detail and critical observer of results and processes
• Understanding of method development and validation processes

Preferred experience

• Thermo LCMS data interpretation or Agilent GCMS data interpretation
• Compound Discoverer (LCMS) or Unknown Analysis (GCMS)
• Unknown compound identification
• High resolution data

Physical requirements

• Must be able to remain in a stationary position 80% of the time
• Ability to continuously operate a personal computer or lab equipment for extended periods of time (4 or more hours)
• Ability to operate a keyboard and other lab equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead
• Ability to communicate clearly and understandably to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting
• Ability to handle small and fragile devices with tweezers and/or fingers
• Require close distance visual acuity with or without correction (glasses, contacts, etc.)
• Must be willing and able to wear PPE such as hard-hat, steel-toed shoes, safety glasses, laboratory coat and/or any other devices or equipment that is required
• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with visitors, ability to complete tasks in situations that have a speed or productivity quota
• Ability to move equipment or items up to 50 lbs

Schedule

Mon-Fri 8am-5pm

Benefits and perks

• Medical, Dental and Vision Coverage
• 401k Company Matching
• Paid Time Off
• Wellness Program
• Education Assistance
• …and more!