Inhalation Study Lead — GMP Analytical Lab

ThermoFisher Scientific; Athlone; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific’s Inhalations team in Athlone, Ireland seeks an experienced Study Lead to manage and execute multiple routine projects, interact with clients and internal stakeholders, and deliver high-quality study outputs in a GMP analytical testing environment.

The role requires 5+ years in a related field, strong HPLC and Empower Software experience, and a commitment to data integrity and regulatory compliance. Training and mentoring of staff are part of the duties.

Qualifikationen

• Bachelor's degree in analytical chemistry, pharmaceutical sciences, or related field.
• 5+ years of relevant industry experience.
• Experience with HPLC and Empower Software in GMP lab.
• Experience with inhalation devices testing (pMDIs, DPIs, nebulizers).
• GMP-regulated environment experience.

Aufgaben

• Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables.
• Reinforces best practices through example and delivery of routine study activities.
• Communicate project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients.
• Execute, manages, oversees multiple routine projects, interacts with clients and internal stakeholders to communicate updates, reviews and evaluates data, writes reports and protocols, and oversees quality records.
• Provide guidance, resources, mentoring, and/or training to laboratory staff, fostering independent routine test execution and troubleshooting.
• Prepare and/or review routine study protocols, project status reports, final study reports, and other project-related technical documents.

Kenntnisse

Analytical chemistry

Project management

Regulatory compliance

Mentoring

Ausbildung

Bachelor's degree in Analytical Chemistry or related field

Tools

HPLC

Empower Software

Jobbeschreibung

Thermo Fisher Scientific’s Inhalations team in Athlone, Ireland seeks an experienced Study Lead to manage and execute multiple routine projects, interact with clients and internal stakeholders, and deliver high-quality study outputs in a GMP analytical testing environment.

The role requires 5+ years in a related field, strong HPLC and Empower Software experience, and a commitment to data integrity and regulatory compliance. Training and mentoring of staff are part of the duties.