Method Development & Validation Specialist

The primary purpose of this role will be to develop and optimise analytical methods along with method validation and transfer according to regulatory guidelines. The role will involve participating in a Professional Scientific Services (PSS) team to ensure the highest quality and productivity standards are met along with the agreed client requirements and timelines.

Job Responsibilities

• Complete analytical data collection, interpretation and characterization of compounds while ensuring proper documentation of experimental data is adhered to.
• Support innovative development of new analytical methods as well as improvement and optimization of current methods.
•  Provide technical expertise and analytical support for the introduction of new products to the Cork site, including method development, validation/qualification and transfer of methods to clients as required.
• Lead in troubleshooting analytical technical challenges during the development, validation/qualification and transfer of methods.
• Communicate regularly with client, providing updates on projects progress, addressing technical queries and delivering client project requirements to the defined timelines.
• Ensure the delivery of projects in the required timeframe and ensure that the site’s technical, quality and safety metrics are all achieved.
• Provides suitable training where required to adopt new practices.
• Review and approve standard operating procedures (SOP's), laboratory methods, control of substances hazardous to health (COSHH) assessments, laboratory investigational reports, validation protocols, Risk assessments, reports & protocols.
• Accountable for adopting the ALCOA+ (attributable, legible, contemporaneous, original & accurate) principles and ensuring team working in accordance with registered methods and current Good Manufacturing Practice.
• Takes a lead role in approval process. As part of this, is responsible for verifying the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria as per relevant SOP's, customer acceptance criteria, methodology, protocol and product specifications.
• Is an analytical expert who provides expertise in laboratory practices and good manufacturing practices (GMP). Uses this knowledge and experience to lead laboratory investigations or project/equipment design.
• Responsible for identifying out of specification results. Designs root causing experiments and retest plans, ensuring investigations are completed in a timely manner and that sound scientific rationale has been employed. 
• Works on long term objectives to deliver specific improvements or embed changes within the laboratory. Takes ownership of project from concept to delivery, providing progress updates throughout lifetime of project.
• Responsible for the scientific conduct of project and communication of regulatory issues with senior level team members.