Assoc Group Leader (Supervisor), Pharma
Thermo Fisher Scientific
- Athlone, Co Westmeath
- Permanent
- Full-time
- 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, 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 for quality system improvements.
- Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
- 1+ year of leadership responsibility
- 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, EMA and FDA guidance's.
- Knowledge and experience of a wide range of techniques, HPLC, UPLC, Mass Spec, GC, Dissolution, etc
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.