This organisation have more than 25 years of experience providing discovery, development and drug lifecycle, offering product development including clinical testing, laboratory services, bio statistical analysis, regulatory services, clinical trial and data management.
Managing a team of analysts you will be part of a fast paced bioanalytical laboratory where you will manage laboratory resources for group project activities and update LIMS for project status. You will be committed to quality results and strict compliance with regulatory standards. Responsibilities of the Lead Scientist will include:
- 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.
The successful Lead Scientist should possess:
- BSc in Biopharmaceutical or Analytical Science or a related Degree.
- 5+ years’ work experience within a GMP laboratory.
- 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.
The successful candidate can look forward to job stability due to year on year growth with future expansion plans, there is huge opportunity to progress in your career with this organisation.
- Generous Salary
- Medical insurance
- Life Insurance
To learn more apply online or contact Orla Boyle directly on +353 91 782110 for a confidential chat.
Salary: €40000 - €55000