Impurities Scientist

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Were looking for a motivated and curious scientist to support testing and method development in our growing lab team. In this role, youll help ensure the quality and safety of our products by performing routine testing and contributing to important lab documentation. If you have a background in the sciences, some hands-on lab experience, and an interest in the biopharma world, this could be a great next step in your career.

Key Responsibilities:

• Conduct routine and complex sample testing in the residual impurity lab within Analytical Sciences
• Author and review Standard Operating Procedures (SOPs) to ensure compliance with regulatory standards and best practices
• Perform ELISA and PCR testing for impurity analysis and characterization
• Analyze and interpret complex data sets, preparing comprehensive reports for internal stakeholders and regulatory submissions
• Collaborate with cross-functional teams to troubleshoot issues and optimize testing processes
• Participate in method validation studies to ensure the accuracy and reliability of analytical procedures
• Maintain detailed laboratory notebooks and electronic records in compliance with GMP standards
• Contribute to the development and optimization of impurity profiles for drug substances and drug products
• Assist in the preparation of regulatory documentation related to impurity testing and control strategies

Minimum Qualifications:

• BS in Biology, Biochemistry, Chemistry, or other related scientific discipline
• 1-3 years of experience in analytical laboratory settings, preferably in the biopharmaceutical industry
• Demonstrated expertise in ELISA techniques
• Ability to work independently and as part of a cross-functional team
• Problem-solving and attention to detail skills
• Strong communication skills, both written and verbal, for effective collaboration and report preparation
• Commitment to maintaining a safe laboratory environment and adhering to all safety protocols

Preferred Qualifications:

• Familiarity with impurity profiling techniques for drug substances and drug products
• Experience with high-performance liquid chromatography (HPLC) and mass spectrometry (MS)
• Experience with PCR and other molecular biology techniques
• Proficiency in SOP authoring and review
• Hands-on experience with method development and optimization for impurity analysis
• Excellent analytical and problem-solving skills with the ability to interpret complex data sets
• Strong communication skills, both written and verbal, for effective collaboration and report preparation
• Proficiency in using laboratory information management systems (LIMS) and other relevant software
• Ability to work independently and as part of a cross-functional team
• Commitment to maintaining a safe laboratory environment and adhering to all safety protocols

What to Expect in the Hiring Process:

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details:

The position is full-time, onsite, Monday through Friday, 8:00 a.m. to 5:00 p.m. Candidates living within a commutable distance of Gaithersburg, MD, are encouraged to apply.

Excellent full-time benefits include:

• comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Pay is between $25 and $29 per hour

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com .

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.