Data Review Scientist- Extractables & Leachables

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.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Perform various tasks and analyses of Bio/pharmaceutical ingredients and products; reviewing/preparing standards and samples for analysis and running a variety of equipment or instrumentation independently; troubleshoot and solve instrumental and/or method problems; working efficiently; ensuring that client received quality data by reviewing laboratory data for accuracy, clarity and adherence to GMP and/or GLP regulations; evaluate current systems and suggest process improvements when appropriate; write complete and detailed investigations independently; support multiple projects simultaneously; demonstrate leadership qualities and train newer analysts.

Extractables/Leachables:

Background:  Bio/pharmaceutical container closure systems, delivery systems, and manufacturing components may contain additives that can leach into the final drug product.  These leachable compounds may pose potential health risks to the patient by increasing the drug’s toxicity or reducing its efficacy.

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.

Essential Duties and 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 
• Regular attendance and punctuality 
• Performs laboratory operations with good dexterity, good laboratory technique, and high degree of accuracy and precision 
• Perform/review preparations of reagents, samples, and standards according to procedures. 
• Perform routine, non-routine and complex analyses; instrumental analyses; including calibration and troubleshooting/repair of instruments independently 
• Demonstrate the ability to multitask 
• Perform all work independently 
• Serve as a trainer for newer analysts
• Review/Document testing, observations, deviations, and results clearly and completely, and in compliance with regulatory requirements - striving to minimize errors 
• 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 
• Demonstrate technical writing skills and initiate/support completing investigations 
• Demonstrate desire to learn independently, including new analytical techniques and nonroutine analyses 
• Demonstrate leadership qualities including;
  • Effective communication 
  • Display confidence
  • Demonstrate motivation and take initiative 
  • Follow through on assignments 
• Process/review data, generate/review reports, and evaluate data 
• Communicate effectively, both orally and in writing 
• Independently seek out work 
• Perform laboratory maintenance if required 
• Support and drive LEAN initiatives 
• Commitment to occasional overtime as workload requires 
• 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 members

Minimum Qualifications:

• Bachelor's degree in Chemistry or related science
• 3 year experience in a GMP lab setting
• Authorization to work in the US without immediate or future sponsorship.
• Good dexterity
• Positive attitude
• Solution driven
• Good work habits (organized, efficient, careful, safety-conscious, accurate)
• Attention to detail
• Sound scientific logic; good oral and written communication skills
• Understanding of instrumentation and/or instrumental theory
• Client service focused
• Personal maturity
• Demonstration of organizational skills
• Ability to work with moderate supervision upon training completion on assigned task
• Ability to handle multitasking
• Technical writing skills

Additional Preferences: 

• Experience operating chromatography
• LC/MS, GC/MS, and/or ICP systems. 
• Experience with extractables and leachables testing 
• Experience with wet chemistry 
• Ability to work one of five days per week on the weekend

Working schedule will be Full-Time, First Shift, M-F 8am-5pm, weekend availability required. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. No relocation assistance will be given. This position is NOT remote. 

What we Offer:

• 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.