Extractables & Leachables Fellow

Summary

Join Eurofins Scientific, a global leader in analytical testing services, and contribute to a safer, healthier, and more sustainable world. As an Extractables & Leachables (E&L) Testing Scientist, you will play a key role in evaluating container closure systems and medical devices for potential contaminants. Responsibilities include performing extractions, analyzing samples using various techniques, identifying unknown compounds, and developing and validating analytical methods. You will also contribute to method optimization, troubleshooting, and regulatory compliance. This position requires extensive experience in E&L testing and chemical characterization, along with strong analytical and problem-solving skills. The ideal candidate will be a proactive team player with excellent communication and leadership qualities.

Requirements

• PhD with 3-5 years, Masters with 8-10 years, or Bachelors with 10+ years industry experience (pharmaceutical and/or medical device) in extractables, leachables (E&L) and chemical characterization testing and experimental design
• Ability to design and aid in the execution of the extractable studies, based on current and evolving industry standards, with a high level ability to diagnose and trouble shoot advanced E&L projects
• Extensive experience with structural elucidation activities such as identification of unknown compounds based on the mass spectral information. Ability to support the continued growth of our internal database for compound identification and help the E/L department fully identify all reportable extractable compounds

Responsibilities

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Applies the highest quality standard in all areas of responsibility
• Demonstrates and promotes the company vision
• Demonstrates strong client service skills, teamwork, and collaboration
• Proactively plans and multitasks to maximize productivity
• Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
• Performs laboratory operations with good dexterity, good laboratory technique, and high degree of accuracy and precision
• Perform preparations of reagents, samples, and standards according to procedures
• Document testing, observations, deviations, and results clearly and completely, and in compliance with regulatory requirements - striving to minimize errors
• Perform routine, non-routine and complex analyses; instrumental analyses; including calibration and troubleshooting/epair of instruments independently
• Make technical decisions without consulting management
• Guide and mentor junior staff to successfully complete projects and grow technical knowledge
• Do independent research into regulatory trends and technical advances
• Present research finds at industry conferences
• Be a technical resource for internal problems throughout ELLI
• Provide support for corporate initiatives through BPT network
• Provide coverage for management when needed
• Understand and perform calculations as required by test methods
• Understand and utilize computers for information access, calculations, and report preparation
• Read and understand analytical procedures (compendial and client supplied) and internal SOP's
• Champion implementation of new techniques, technologies and instrumentation
• Provide consultation for clients
• Demonstrate technical writing skills and complete investigations independently
• Demonstrate leadership qualities including; Effective communication, Display confidence, Demonstrate motivation and take initiative, Follow through on assignments
• Process data, generate reports, and evaluate data
• Communicate effectively, both orally and in writing
• Suggest and implement lab improvements or modify existing processes to maximze quality and productivity; support and drive LEAN initiatives
• Conducts all activities in a safe and efficient manner
• Ensures good housekeeping with a neat, clean and orderly workspace
• Performs other duties as assigned
• Communicates effectively with client staff me

Preferred Qualifications

• Fully up-to-date on industry and regulatory expectations for E/L study design and execution. Ability to drive science-based improvements to our E/L approach that are in line with regulatory expectations
• Experience in a cGMP, GLP, and/or ISO 17025 compliant/accredited lab
• Strong method development, troubleshooting and method optimization skills associated with mass spectrometry methodologies. The optimal candidate will be able to diagnose and identify any problematic methods and adequately adjust for complex matrices
• Extensive experience/education with organic chemistry, polymeric science, and/or material science to assist with identification of unknown compounds
• Extensive analytical chemistry experience with the ability to evaluate new testing inquiries and help establish/onboard new instruments, methodologies, and analytical testing
• Ability to work partially or fully on-site in Lancaster, PA, but will consider remote employees

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays