Company Description

**We have an opportunity for a Compendial Compliance Specialist  to join our PSS Site in Ringaskiddy****

The purpose of this job is to serve as a member of the Cognition team within the client environment to support their technical and analytical tasks, to work to the highest standards in terms of quality and professionalism.

What can Eurofins offer you as an employee of ours?

Developmental opportunities and career progressionThe opportunity to work with our client - a world -leading pharmaceutical and biotechnology companyLocation is easily accessiblePrivate Medical Insurance Income protection and life assuranceAnnual discretionary bonusFree parking onsiteFull use of the canteen facilities on the client siteAdditional annual leave days with continued serviceThe opportunity to work on therapeutic drugs helping to save lives across the world

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

Job Description

The main purpose of the Associate Scientist -Compendial Compliance role will be to support the BTDS-AD team in Compendial Compliance acting as Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.

Job Responsibilities

Subject Matter Expert: Act as a Large Molecule, Subject Matter Expert (SME) solely responsible for ownership of compendial and particulates methods in maintaining applicable regional compliance.The scope of the methods encompasses methods such as - pH, Color, Turbidity, Osmolality, Turbidity, Moisture, Extractable Volume, Visible Appearance, Sub-Visible Particulates and MDI.Clinical Product Lifecycle Management: Lead/deliver the clinical product lifecycle management from Phase I-III with regards to product presentation and formulation changes and manage the co-ordination of the demonstration of method robustness. Support the clinical to commercial product transition in relation to method/instrumentation performance and laboratory investigations, as applicable.Regulatory Filings: Ability to author the Product Regulatory Section Submissions/Responses to support IND/BLA Filings, as required.Ability to advance and shape the BTDS AD Cork technical analytical capabilities in-line with industry standards.

QualificationsA degree or diploma in chemistry or a related discipline3rd Level qualification in science, administration or other relevant disciplines is preferable3 years’ experience in a relevant testing/Compendial roleThe successful candidate will be a motivated self-starter, capable of working under their own initiativeExcellent interpersonal and verbal and written communication skills are essential for this role.

Additional InformationThis is an opportunity to join Eurofins on a full time permanent basis. Working a flexible 39 hour week.Benefits of pension contribution, medical insurance, health insurance and bonus are included in package. Eurofins Management and Team on client site for support.Opportunity to get to know fantastic people and be part of a great team. 

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 50,000 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.