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Associate Group Leader

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Westmeath
  • Sector: Science
  • Date posted: 13/07/2017
  • Job reference: J362046A

Description

Associate Group Leader required for Permanent role with well Known Contract Research Company in Westmeath.

Key responsibilities:

  • 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 prioritising 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.

Qualifications

  • 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 information contact James on 016455250 or email

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