The role of Associate Group Leader is to provide support to one of our laboratory groups who work with multiple pharmaceutical products and formulations including tablets and capsules (Small Molecules department).
You will achieve this by providing management and direction to laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs. You will have ownership to ensure responsiveness to the client and overall client satisfaction. This position is lab based, with direct supervisory responsibilities of a small group of Scientists.
- 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.
Skills and experience:
- Educated to a Bachelor's Degree level in a relevant area, ie chemistry.
- 5+ years experience within GMP using a range of analytical techniques including but not limited to HPLC, GC, UPLC, ICP, MS, LCMS, AA.
- 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, ICH guidelines, EP and USP requirements and EMEA and FDA guidance's.
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671