Standardised Methods Specialist

at  Eurofins Ireland PSS

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
• The 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 Standardised Methods Specialist 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.

QUALIFICATIONS

• A degree or diploma in chemistry or a related discipline
• 3rd Level qualification in science, administration or other relevant disciplines is preferable
• 3 years’ experience in a relevant testing/Compendial role
• The successful candidate will be a motivated self-starter, capable of working under their own initiative
• Excellent interpersonal and verbal and written communication skills are essential for this role.

• 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