Principal Toxicologist

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.

Job Description

As a Toxicologist your responsibilities will include, but are not limited to, the following:

• Prepare hazard identification and toxicology risk / safety assessments for impurities, excipients, leachables, extractables, etc.
• Conduct SAR and QSAR modelling of compounds
• Review, interpret, and position data (study reports, literature, safety data)
• Conduct technical dossier gap analysis and independent data reviews
• Validity review of performed studies
• Remain abreast of advances in the field
• Actively participate in US working groups for standards development (e.g., AAMI)
• Provide technical support and guidance on client calls
• Serve as a thought leader and mentor to junior members of the team

Essential Duties and Responsibilities:

• Applies GMP/GLP in all areas of responsibility, as appropriate
• 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/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
• 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
• Be a technical resource for internal problems throughout ELLI
• Provide support for corporate initiatives through BPT network
• Provide coverage for management when needed
• 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
• Assist with onboarding new instrumentation, including performing/reviewing IQ/OQ/PQ data or qualifications
• 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/review data, generate/review reports, and evaluate data
• Communicate effectively, both orally and in writing
• Suggest and implement lab improvements or modify existing processes to maximize quality and productivity; support and drive LEAN initiatives
• Support or identify speaking or publishing opportunities and assist with driving to publication or presentation
• Commitment to occasional overtime as workload requires

Minimum Qualifications:

• Bachelors Degree in Toxicology or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
• Authorization to work in the US without immediate OR future sponsorship 
• Minimum of 10 years’ experience performing biological evaluations of medical devices per ISO10993 (i.e., authoring biological evaluation plans (BEPs), biological evaluation reports (BERs), and toxicological risk assessments (TRAs) 
• Strong understanding of the full scope of ISO 10993 as well as other relevant industry and regulatory standards
• 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 multiple instrumentation platforms and/or instrumental theory; client service focused; demonstration of organizational skills; ability to independently work on complex projects; ability to multitask; technical writing skills

Additional Preferences:

• Certification as a Diplomate of the American Board of Toxicology (DABT) 
• Involvement and leadership in relevant international standards committees (e.g., ISO, AAMI, etc.) 
• 10 years experience in performing biological evaluations of medical devices on the basis of ISO10993-17. 
• Advanced degree in toxicology or related degree concentration 
• Familiarity with a broad range of medical device applications
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Strong leadership, initiative, and teambuilding skills

Working schedule will be Full-Time, First Shift, 8am-5pm M-F. Overtime may be required when necessary. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. 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.