Due to the expansion in 2016 of our Ireland labs following continued success and growth, PPD is currently looking to recruit an Associate Group Leader to be based in our Biopharm department of our GMP Lab in Athlone, Ireland.
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.
Education and Experience:
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