Analyst - BioPharma Product Testing Inc.

Overview

Eurofins Scientific is an international life sciences company, providing analytical testing services to clients across multiple industries to make life and the environment safer, healthier and more sustainable. Eurofins works with the biggest companies in the world to ensure products are safe, ingredients are authentic and labeling is accurate. It is a global leader in food, environmental, pharmaceutical and cosmetics testing and in genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and clinical studies support.

In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR 6.515 billion.

Reporting directly to the Director - Chemistry, the Analyst I will provide basic technical support and analysis within the Biopharmaceutical Chemistry Testing Laboratory. This is a deadline-based, high-pressure work environment with on-going projects for a variety of clients.

The Analyst I will have over 2 to 5 years of laboratory testing experience with demonstrated ability to complete duties that are more complex. They will have handled a variety of instrumentation for analytical testing and be able to work independently with minimal/no supervision. The incumbent must be energetic, well-organized, flexible, and able to interact with customers and staff in a fast-paced environment, sometimes under pressure, while remaining proactive, resourceful and efficient.

A high level of professionalism and confidentiality is crucial to this role.

The Analyst I must:

• Perform method development, method validation, method transfer and routine analyses using ICP-OES, ICP-MS and Atomic Absorption spectrometer instrumentation.
• Review data, prepare protocols and reports to ensure Chemistry projects meet the timeline.
• Train new Analysts to perform ICP-MS techniques.
• Perform sample preparation and analysis and execute a number of routine/non-routine methods and procedures including method development, validation, verification and sample testing.
• Perform instrument calibration, qualification and preventative maintenance program as necessary.
• Perform investigations and troubleshoot non-confirmatory results or methods.
• Ensure that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Analyze API, Raw Materials and Finished products for Assay of multiple elements, heavy metals.
• Recognize OOS or out of trend results and assist laboratory manager in the completion of lab investigations.
• Process and report analytical results.
• Update and report work into LIMS.
• Review technical data, documents, and proposals as required.
• Proficient in Microsoft Office programs (Outlook, Word, and Excel).
• Hands on experience with pharmaceutical data acquisition software e.g. Syngistix, e-LIMS, ETQ etc.
• Troubleshoot technical issues/difficulties with methods.
• Coordinate with team members to perform method transfers between R&D group to QC group;
• Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures.
• Be experienced on a number of wide variety of routine and some non-routine wet chemistry methods and procedures.
• Strong interpretation of routine analysis or tests.
• In-depth understanding of chromatography principles, types and techniques.
• Have high troubleshooting skills, both with instruments and methods.
• Apply technical judgment to determine potential problems for samples.
• Competent research and study skills to learn about innovative methodologies and equipment used for problem solving and troubleshooting.
• Accountable for the integrity and traceability of all data generated and reported.
• Design, preparation, and production of study materials including procedure manuals.
• Perform other duties as assigned by Laboratory manager.

• Sample preparation using various wet chemistry techniques, extraction of heavy metals using conventional digestion/microwave digestion techniques
• Documentation:
  Ensuring accurate reporting in lab books.
• Using a wide range of sophisticated equipment and instruments to conduct analysis and research and troubleshoot instrumentation/methods
• Perform other departmental tasks such as cleaning, supply ordering, assist with instrumentation training and maintenance, etc
• Perform analytical tests utilizing ICP-OES, ICP-MS and Atomic absorption spectrometer, UV, IR, FTIR, KF and other laboratory instruments.
• Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations
• Writing SOPs
• Ensure that work is performed in compliance with GMP, SOPs and current test method.
• Participates in general lab…