Methods and Validations Lead Technologist

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 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 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

•    Ability to manage, instruct and train technologist in all aspects of laboratory testing. Provides training to staff based upon established procedures and regulations. Ensures policies and procedures are followed and that training is complete for all staff members
•    Manages technologist scheduling to ensure coverage for testing performed. Establishes priorities and assigns specific activities to technologist
•    Oversees the operation of the laboratory which includes but is not limited to overseeing testing volume, supply inventory, ordering, and maintenance of the work area
•    Provides leadership in the department as an acting mentor and role model for staff. Serves as a resource for technologist and department management
•    If applicable, directs internal proficiency/competency program according to regulatory standards and operating procedures
•    Properly escalates problems to supervisor
•    Provides input on employee performance to manager as directed for employee reviews
•    Assists with personnel management including but not limited to scheduling, minor conflict resolution, training, and competency
•    Performs sample setups including but not limited to: quarterly dose audit testing (sterility and bioburden), method suitability protocols, validations, and customer studies. Follows written instructions for the handling, management, and analysis of samples in compliance with established procedures and quality regulations
•    Performs culture reads and identifications for all related testing
•    Generates dose audit reports and ensures data and analysis is captured accurately 
•    Laboratory maintenance (cleaning, prep…)
•    Writes the design and development of validation protocols and support the reviews of the protocols to ensure the purpose, testing, and intended outcomes are defined and in compliance with this sites Method Validation program and applicable standard requirements. Provides technical input to leadership regarding the onboarding of a new product to our site. Develops performance specification for new methods
•    Serves as a department-related content subject matter expert. Serves as a liaison for the department to other internal departments
•    Aides in implementing changes and corrective action to help with process improvement
•    Works closely with various departments providing method suitability support for the routine testing departments 
•    Utilizes laboratory information systems or other methods to accurately and effectively report results. Operates within our Laboratory Information Management System. Reports test results conforming to established procedures
•    Prepares reagents or media from a prescribed procedure
•    Writes laboratory procedures conforming to standardized format including revising Standard Operating Procedures
•    Understands the application of regulatory standards and guidance documents. Comfortable in interacting with clients or regulatory bodies
•    Active participation in QMS program: Specimen investigations and investigation summaries. Identifies and assists with resolution of deviations encountered during testing executions
•    Monitors