***Opportunity for an experienced Lead Microbiology Analyst in our new client site in, Co Carlow***

The primary purpose of this role is to lead a Professional Scientific Services (PSS) team of analytical staff to ensure that team is operating at the highest quality and productivity standards, have high morale and retention, and the agreed client requirements are entirely satisfied and that client expectations are met or exceeded through effective leadership and quality operational management, under the supervision of the PSS Manager. This person will be a key point of contact for the client on a day-to-day basis while performing validation project work in a new Microbiology laboratory, inclusive of equipment qualification, method transfer and qualification. Performance qualification and set up of laboratory for water testing, bioburden, endotoxin and product testing.

What can Eurofins offer you as an employee of ours?

• Developmental opportunities and career progression
• The opportunity to work with our client - a world -leading pharmaceutical and biotechnology company
• Location is easily accessible
• Private Medical Insurance
• Income protection and life assurance
• Annual discretionary bonus
• Free parking onsite
• Full use of the canteen facilities on the client site
• Additional annual leave days with continued service

Consider joining Eurofins, where people are the most important element in our business. Eurofins is a leading contract research organisation providing testing and research services in the pharmaceutical and biopharmaceutical sciences to clients worldwide.

This position is to join our innovative Professional Scientific Services (PSS) programme as an employee of Eurofins. The programme places full-time analysts, technicians, scientists and technical support personnel managed by Eurofins directly at the client facility to provide long term staffing needs while maintaining the same services, expertise and cGMP compliance available at the Eurofins facility. This award-winning programme offers excellent career opportunities for people who have a proven track recording in combining excellent technical ability with first class interpersonal and communication skills

• Work with the PSS Manager to effectively coordinate and lead the PSS team so that productivity, quality, documentation, work schedules, safety and housekeeping are run at maximum efficiency.
• Ensuring that the client gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
• Set up a laboratory including drafting general standard operating procedures (SOP’s)and Micro specific SOPs
• Work with Operations, Quality Assurance, and the Projects team on authoring qualification protocols
• Oversee vendor qualification of equipment and manage equipment Performance Qualification projects
• Manage Method qualification, method transfer and method verification for sterility, Bioburden and endotoxin and new product introduction
• Review and QC release of laboratory reagents including biological indicators, microbiological cultures, media and endotoxin challenge vials
• Provide support and subject matter expert knowledge in investigations associated with deviations
• Notify the client representative, any anomalous or out of specification results and participate in the investigation as appropriate.
• Developing training materials and delivering training to other team members as required. Ensuring all training delivered is documented appropriately.
• Dealing with client queries and to contact designated personnel with any relevant information or issues relating to test results or the service in general.
• Participating in all training required by the client quality system. Being prepared and on time for that training. Engaging in training processes and ensuring all information received is completely understood.
• Maintain a clear understanding of all related client supplemental processes such as deviation handling, training documentation, document and records control and help others achieve the same.
• Maintain a clear understanding of the client relationship and service goals and help others achieve the same. Maintain a clear understanding of the client process flow in terms of destination and use of data generated, and consequences of sub-standard data, and help others achieve the same.
• Keeping up to date with any technological or method revisions in their area, ensuring their training is complete and adjusting their work as required in collaboration with the client.
• Performing second person verification checks as required by the laboratory schedule.
• Development, coaching, motivation, and morale of team members through effective teambuilding and use of reward and recognition systems and celebrating team success.
• Participating in the preparation of and execution of the PAD reviews. Organising and executing regular one-to-ones with your team.
• Participating in the preparation and execution of Team Meetings, with the assistance of the PSS Manager.
• Being the main point of contact for the team and the client in terms of service provision discussions.
• Reviewing and approving all relevant documentation in a timely manner and ensuring that it is communicated, documented, filed accurately, and compliant with the required standards.
• Reviewing and improving commercial work practices. Identify areas where efficiencies may be improved and liaising with the PSS Manager and client appropriately about any proposed improvements. Encouraging others to do the same.
• As relevant, ensuring that work is scheduled and cross training takes place as requested so that the service levels agreed with the client are achieved. Responsible for amending schedules in the absence of the PSS Manager or as required and communicating those changes effectively.
• Write SOP’s, protocols, trending reports on an on-going basis, as required.
• To address group local audit findings in conjunction with the client if required.
• Once foundational knowledge is in place start to identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.

• A Degree in Microbiology or related discipline.

Experience / Skills

• A minimum of 4 years’ relevant experience of Microbiology within a GMP environment
• At least 1 years’ experience in a supervisory/leadership capacity is an advantage
• Subject Matter Expert in applicable microbiological tests (Sterility, Endotoxin, Bioburden and method qualifications.
• Laboratory Quality Systems, GLIMS and SAP
• Full understanding of requirements for working in a GMP environment.
• Ability to quickly learn new processes.
• Ability to communicate clearly and to form strong working relationships with direct reports, client contacts and PSS manager
• Willing to operate in a flexible manner and able to reuse both internal and external experiences and incorporate them into relevant improvements. Ability to switch priorities at short notice.
• Good team player, organised, accurate, have strong documentation skills.
• Passionate about quality and customer service.

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 58,000 staff across a network of more than 1000 independent companies in over 54 countries and operating more than 900 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 € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.