Scientist LC/GC Data Interpretation, Medical Device

Job Description

Example of a case study:

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).

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 - must have experience with data interpretation/compound identification.
• LCMS/GCMS & 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 & critical observer of results and processes.
• An understanding of method development and validation processes.

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 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.

Additional Information

• Compensation is aligned with market standards for the region and tailored to individual qualifications and experience.
• Schedule: Mon-Fri 8am-5pm