Director, Bioanalytical Operations

Company: Eurofins Scientific
Location: Saint Charles
Posted on: February 25, 2021

Job 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 2019, Eurofins generatedtotal revenues of EUR --- 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Eurofins BioPharma Services Services, US is searching for a--Director, Bioanalytical Services in St. Charles, MO. The Director, Bioanalytical Operations is responsible for ensuring contract services are delivered to clients according to internal standard operating procedures and current industry standards. This position is responsible for managing scientific staff and supporting lab operations while driving scheduling of Sample Analysis, QC Review, and Technical Writing activities to meet timelines, revenue and profit plans. Essential Duties and Responsibilities: Sample & Reagent Management, Sample Analysis, QC Review, and Report Writing teams to ensure on-time delivery of services according to internal and external customers program needs Manages Facilities & Metrology department according internal SOP and current industry/regulatory standards.-- Manages team to ensure that service quality is maintained and in line with current SOPs and regulatory needs, as appropriate Drive schedules that meet client projects, planned revenue, and profit targets Responsible for data review, analysis review, and ensuring accuracy and integrity of data reporting Responsible for critical reagent oversight, scheduling, inventory, and forecasting Tracks and reports the following KPIs: Analysis Utilization rates, Sample and Plate passing rates, Peer review documentation accuracy rates Provides scientific guidance that supports technical writing Provides guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner Serves as Principal Investigator or Lead Scientist as needed Responsible for the data developed by the department to ensure compliance with study requirements, accuracy and consistency and compliance with the regulatory requirements Plans and coordinates the daily service operational activities with the appropriate staff and related operations/activities as needed ensuring that work is scheduled and completed to deliver data and reports to clients in a timely manner in compliance with regulations and the Company's quality system Understands and follows all procedures and processes required for work performed under Regulatory Compliance (i.e. GxP, FDA/GLP and GCP, OECD, CLIA, etc.) and attends annual GLP training Directs investigations of service operations, such as deviation reports, non-conforming reports, corrective action reports, etc.; produces documentation according to established standards Reviews and approves operations documents to assure consistency with regulatory standards and requirements. (i.e. SOPs, batch records, training records, etc.) Develops process improvements to drive efficiency gains while maintaining highest quality levels Mentors and develops employees through objectives and performance management Manages team to ensure provision of a high level of customer and technical service support for all services Facilitates flexibility within team to meet shifting business needs Develops new ideas for new services offerings Contributes to tactical and strategic marketing practices for site services Implants and nurtures the corporate values within the department and guarantee commitment to these by all team members Provides technical input to business development activities and in support of client relationships, as required Conducts all activities in a safe and efficient manner Demonstrates and promotes the company vision Strong understanding and practice of project management skills Regular attendance and punctuality with ability to work overtime to accommodate business need High work ethic Knowledge of laboratory EHS practices and requirements for biologicals and chemicals Applies GMP/GLP in all areas of responsibility, as appropriate and understands and follows all written procedures that apply to the function of the position Position is full-time, Monday-Friday, 8:30 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of St. Charles, MO--are encouraged to apply. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options. Master's Degree or higher, 5 years in lab operations management/supervisory role, Ligand Binding Assay experience Scientific method development and validation of large molecules/biologics for pharma drug development Project management of complex projects Direct client communication and interaction Contract terms and implications Scientific personnel and lab management of at least 5 employees Process excellence Bioanalytical or CMO experience a plus Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Other jobs at Eurofins USA BioPharma Services

Keywords: Eurofins Scientific, Rochester , Director, Bioanalytical Operations, Executive , Saint Charles, Minnesota