Senior Scientist - Chromatography/Mass Spectrometry

Eurofins • New Berlin, WI

23h

About The Position

Position Summary:
The Senior Scientist oversees, performs, and manages testing activities as directed by Specialty Analysis Manager, or Designee, in accordance with all applicable company and regulatory guidelines. Designs experiments, operates, and maintains instruments, assists other chemists, collects and interprets data, writes and peer reviews data and/or reports especially for challenging, non-routine investigations, custom method development, method validation, and unknown/material identification. Experienced in nontargeted analysis, deconvolution of mass spectral data, and structural elucidation.
Authority:
The Senior Scientist receives sufficient authority from, and is accountable to, the Specialty Analysis Manager, or appointed designate, for the successful completion of assigned duties and responsibilities and has the authority to take action necessary to carry out the duties and responsibilities of this position and to identify the occurrence of departures from the quality system or from the procedures for performing tests and/or calibrations, so long as such action does not deviate from established company guidelines, is consistent with sound technical and business judgment, and follows the practices of the laboratory.

Requirements

• MS or PhD in Chemistry or related field, or BS and 5+ years’ experience in a commercial laboratory.
• Minimum 3+ years of experience in E&L testing, ideally within a regulated environment.
• Extensive experience required in the development and execution of HRMS methods using Thermo Exploris LC-Orbitrap-MS or equivalent instrument(s), and related techniques.
• Experience with software for data analysis (e.g., MassHunter, Empower, Chromeleon, Compound Discoverer, and TraceFinder).
• Proficiency at GCMS, HPLC, LC-MS and knowledge of all other major analytical instrument capabilities is imperative.
• Knowledge in High Resolution Mass Spectrometry interpretation is a must.
• Troubleshoot instrumentation and analytical issues, maintain lab equipment, and ensure quality standards are met throughout testing procedures.
• Knowledge of ISO 17025, FDA E&L/Migration, and related guidance.

Responsibilities

• Perform, manage, and oversee testing activities as directed by Specialty Analysis Manager, or Designee, in accordance with all applicable company and regulatory guidelines.
• Manage assigned testing to ensure quoted turnaround times are met.
• Wet chemistry techniques utilized will include but are not limited to chromatography, gravimetry, titrimetry, colorimetry and others as needed including sample preparation, isolations, filtrations, extractions, evaporations, and derivatizations following established test protocols.
• Plan, conduct, and document extractables and leachables testing using techniques such as HS-GC-MS, GC-MS/FID, LC-HRMS, GC- & LC-MS/MS, IC and HPLC and other instruments and techniques as needed to meet customer expectations.
• Develop and validate high-resolution mass spectrometry analytical methods according to regulatory and industry standards (GLP, ISO, FDA) and ensure reliable, reproducible results.
• Analyze complex data sets using deconvolution software (e.g., Compound Discoverer) and structural elucidation of non-targeted masses.
• Peer review proposed study/method protocols, and peer review completed reports for development work, and method validation/verifications.
• Design custom projects or studies; and offer interpretation, custom reports, or consultation on test data.
• Enter testing data into LIMS and monitor for QC failures.
• Assist lab staff in determining corrective actions for QC failures.
• Review and approve laboratory analytical data including peer review.
• Review and issue reports to clients.
• Maintain chemical/reagent traceability.
• Support the maintenance of controlled documents related to laboratory operations/testing through editing of documents and/or reviewing revisions in our DMS.
• Support quality system improvements through completion of Corrective and Preventive Action forms, documenting Non-Conformances and Client Complaints, and assisting with internal audit findings as assigned by Quality Manager.
• Support the completion of unknown and failure investigations through testing performance and/or imparting chemical knowledge.
• Maintain regular attendance and punctuality.
• Conducts all activities in a safe and efficient manner.
• Performs other duties as assigned.
• Assist with case studies, white papers if requested by Sr. Management for marketing purposes.
• Attend industry-appropriate symposia, training, webinars, journals to remain current on analytical techniques, new developments.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level