Associate Group Leader
Associate Group Leader required to join a leading contract research organisation in Athlone, Ireland. This role will be based in the Biopharmaceutical department of the GMP Lab.
- Management of a team of analysts
- Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
- Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
- Designing experimental study and participates in technical troubleshooting.
- Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.
- Responding to client questions and needs; leads client technical meetings.
- Assisting in preparation of proposals, project definition and pricing.
- Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.)
- Assisting senior group leaders and/or managers in their responsibilities.
- Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations to quality system improvements.
- Educated to a Bachelor's Degree level in a relevant area
- Management experience in the pharmaceutical, biotech or analytical contract laboratory industries.
- Stability/QC/analytical R&D/project and program management.
- Direct supervision of technical staff.
- Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
- Knowledge and experience of a wide range of techniques; HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.
- Experienced in method development and validation.
For more info on this role contact Paul on 01 6455250 or email