Extractables & Leachables Fellow

Job description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

What do we do:  The Extractables & Leachables Testing department evaluates container closure systems, delivery systems, manufacturing components, and medical devices for extractable and leachable compounds.  This process involves exposing the materials to extraction solvents and then testing the resulting extraction solutions by a variety of analytical techniques.  These screening methods require extensive data interpretation in order to identify the compounds using proprietary databases.

Center of Focus:

• Extractables – team members will perform worst case extractions on various materials and then test the resulting extraction solutions to determine what compounds may be extracted out of the materials under exaggerated conditions
• Leachables – team members will test drug product that has been stored in the container closure system to determine what compounds will leach out of the materials and into the drug product under the actual conditions of use.
• Development and Validations – team members will establish method conditions that meet the intention of the analytical method and then perform a series of tests (e.g., precision, accuracy, linearity, specificity, and sensitivity) to ensure the method is appropriate for its given function.
• Unknown Peak Identifications – team members will perform investigative testing in an effort to identify unknown compounds.  This testing typically relies on mass spectrometers that are capable of fragmenting the unknown compound.

Position Details:

· 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

Qualifications

Basic Minimum Qualifications:

• 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.

Additional Preferences:

• 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.

Additional Information

Position is full-time, working Monday-Friday 8am-5pm, overtime as needed.  Candidates currently living within commutable distance to Lancaster, PA are encouraged to apply.

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

Eurofins USA Medical Devices is a Disabled and Veteran Equal Employment Opportunity employer.