Our client is a leading Biopharma, based in Cork. They are seeking an Associate Scientist for their technical Services team. The ideal person shall have a strong GMP background with 5+ years experience.
Leads technical support activities related to maintaining commercial product supplies through management of internal and external resources.
Contributes to and leads complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
Contributes to and leads technical investigations of process deviations, and assessment of their impact on product quality. Defines requirements for, and reviews master batch records.
Contributes to user requirement specification and provides expert process technical support to utilize and validate new and improved technologies.
Liaises with manufacturing groups to deliver new and improved drug products and processes.
Can lead one or more specific components of departmental strategic initiatives.
Revises, improves or develops new methods to support commercial products; writes protocols and reports.
Assists with bench experiments to support collaborations with external researchers
Identifies and introduces new technology and/or methods to the organization, and trains junior staff on their implementation.
Analyzes and identifies risks with processes, technologies and methods, creates a working plan to prevent potential issues.
Designs experiments and ensures they accomplish goals.
Identifies opportunities to improve processes within the business and provides technical expertise and support to process improvement efforts.
May supervise personnel, including organizing and prioritizing daily tasks, and performing training.
5+ years relevant GMP experience and a BS degree or MS degree in a relevant scientific discipline.
Or fundamental relevant experience and a PhD degree in a relevant scientific discipline.
Demonstrates a working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).
Demonstrates excellent verbal, written, and interpersonal communication skills.
Demonstrates strong computer, organizational, and project management skills.
For further details plesae contact Karen Shiel at 087 7452487 or send CV to email@example.com