This GMP laboratory based in Athlone, Ireland offers fully integrated solutions for product development and analytical development, including analytical testing services in method development, method validation, method transfer, release and stability studies. Their highly qualified GMP lab staff work with large and small molecules, including active pharmaceutical ingredients (API), drug products, inhaled products and other medical devices.
Due to further expansion of the site in Athlone, Ireland in 2018, they have a new opening for a Laboratory Supervisor (known locally as Associate Group Leader) in their Small Molecules team.
About the Laboratory Supervisor/Associate Group Leader position
They provide laboratory services that are designed to provide the best and highest level of service to their clients. Their lab employees are committed to quality results and strict compliance with regulatory standards.
The role of Associate Group Leader is to provide support to one of their 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.
• 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.
• Expertise in the application of various analytical instrumentation: HPLC, GCMS, LCMS, IC, AA, ICP etc
This role offers an excellent opportunity for someone who has worked at a Senior Analytical level mentoring more junior analysts, to progress to Supervisory level in a fast paced growing company, dealing with a broad range of products and techniques.
The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. With future expansion plans, there is the opportunity to progress in your career with this company. They offer a generous salary, medical insurance, pension, life insurance and relocation assistance to those qualified candidates based outside of the Republic of Ireland.
They are offering a €5,000 joining bonus for successful candidates.
If you would like further Information you can contact the recruiter directly:
Libby Ryan | Tel: +353 (0) 1 507 9254