Device Development Chemist: Scientist II

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 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.

Job Description

The candidate will be responsible for the following activities:  

• Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.  
• Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, and reports with minimum supervision. 
• Perform test method qualification and GMP testing in support of device verification & validation testing.  
• Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. 

Qualifications

• Hands on technical experience with Container Closure Integrity (CCI) test methods 
• It’s a plus to be an accomplished user of Container Closure Integrity (CCI) techniques and test methods used for parenteral products. (such as Dye Ingress, High Voltage Leak Detection (HVLD), Mass Extraction, or vacuum decay, …) 
• Experience with testing software/tool/equipment such as INSTRON tensile test machine, confocal and/or light microscopy, Solidworks, Minitab, Labview, Matlab and etc.   
• Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.  
• Knowledge of medical / combination device verification & validation is a plus. 
• Knowledge of global industry standards (ex ISO, AAMI, ANSI, etc..) applicable to device and/or combination product development is a plus.

Additional Information

Authorization to work in the United States indefinitely without restriction or sponsorship

• Position is full-time, 5 days per week, 8 hours per day, Monday - Friday, Hours: 10:00 am – 6 pm. Candidates currently living within a commutable distance of Gaithersburg, MD are encouraged to apply.
• May be requested to work on weekends, overtime, and holidays based on business needs.
• 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.